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Spirometry guideline

Queensland Health Guideline


QH-GDL-968:2021

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1. Purpose
This guideline provides recommendations to support high quality spirometry testing throughout
Queensland Health.

2. Scope
This Guideline provides information for all health professionals, and organisations who perform
spirometry on adult and paediatric patients in Queensland Health facilities.
This guideline provides the minimum requirements for obtaining acceptable and repeatable spirometric
data for pre/ post-bronchodilator responsiveness testing using flow-measuring devices.

This guideline assumes operator training in performing spirometry is completed and the attainment and
maintenance of competency is integrated in any spirometry testing service1.
Note: Thoracic Society of Australia and New Zealand (TSANZ) accredited respiratory laboratories, local
policy and procedure manuals that interpret the international standards should be used for conducting
spirometry testing.

3. Related documents
Standards, procedures and guidelines
• Standardisation of Spirometry 2019 Update1

• Guide to Informed Decision-making in Health Care 2

• Australian Guidelines for the Prevention and Control of Infection in Healthcare 3

• General considerations for lung function testing4

• Standardisation of spirometry 20055

• 2007 American Thoracic Society and European Respiratory Society Position statement: pulmonary
function testing in preschool children6

Forms, templates
• Nil
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Spirometry guideline – Queensland Health Guideline


4. Guideline for performing spirometry
4.1. Emergency protocol
̵ Follow all Hospital and Health Service (HHS) protocols in the event of an
emergency.

4.2. Infection control procedures


̵ Testing patients with confirmed or suspected communicable diseases poses a
risk to staff and other patients due to potential cross-infection and is a relative
contraindication to testing. Adhere to HHS infection control protocols and
procedures at all times and in all facets of spirometry testing, in addition to any
updates from respiratory professional societies (e.g. ANZSRS).
̵ Specific infection control procedures pertaining to spirometry testing are
outlined in Appendix 1.
̵ Australian Guidelines for the Prevention and Control of Infection in Healthcare 3

4.3. Gaining consent


̵ Gain consent in accordance with Queensland Health’s Guide to Informed
Decision-making in Health Care 2

4.4. Identifying indications and contraindications for spirometry

4.4.1. Indications for performing spirometry1


̵ Spirometry has a variety of uses including:
• assisting with diagnostic evaluations
• monitoring of pulmonary function
• evaluating disability or impairment
• providing public health information
• pre-employment and lung health monitoring
For detailed indications, refer to Appendix 2.

4.4.2. Relative contraindications for performing spirometry1


Relative contraindications listed in Table 1 do not preclude spirometry but should be
considered when ordering spirometry. The decision to conduct spirometry is determined
by the requesting health care professional based on their evaluation of the risks and
benefits of spirometry for the patient. For example, the test should only proceed if testing
cannot be safely deferred until a contraindication no longer exists. In such circumstances
the patient should be informed of the risk and clear documentation made of the reason
for progressing despite the presence of a noted contraindication.

Table 1. Relative Contraindications for Spirometry

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Due to increases in myocardial demand or changes in Due to increases in intrathoracic and intra-
blood pressure abdominal pressure*
 Acute myocardial infarction within 7 days  Presence of pneumothorax
 Systemic hypotension  Thoracic surgery within 4 weeks
 Severe hypertension (Systolic ≥180mmHg;  Abdominal surgery within 4 weeks
Diastolic ≥120mmHg)  Late term pregnancy
 Atrial/ventricular arrythmia
 Non-compensated heart failure Infection control issues
 Uncontrolled pulmonary hypertension  Active or suspected transmissible respiratory
 Acute cor pulmonale or systemic infection including tuberculosis.
 Clinically unstable pulmonary embolism  Physical conditions predisposing to
 History of syncope related to forced transmission of infection, eg haemoptysis,
expiration/cough significant secretion, oral lesions or oral
bleeding
Due to increases in intracranial/intraocular pressure
 Cerebral aneurysms Conditions which may cause inaccurate
 Brain surgery within 4 weeks spirometry results:
 Recent concussion with continuing symptoms  Pain during the procedure from any cause
 Eye surgery within 1 week  Poor patient compliance due to lack of co-
operation, dementia or confused state of
Due to increases in sinus and middle ear pressures mind
 Sinus or middle ear surgery or infection within 1  Stress incontinence
week  Recent alcohol consumption
 Nausea, vomiting or diarrhoea
*Evidence shows no adverse event for abdominal aortic aneurysm
(AAA) <13cm and thoracic aortic aneurysms (TAA) <8cm

4.5. Facilities and equipment

4.5.1. Testing facilities


Ensure clearly defined rooms are available for spirometry testing, particularly for patients
with confirmed or suspected communicable diseases and immuno-compromised patients.
Specific infection control procedures pertaining to spirometry testing are outlined in
Appendix 1.
Ensure sufficient space allocation for un-restricted movement of patients confined to a
wheelchair and accommodation for staff who may require mobility assistance.

For information relating to testing facility requirements when working with paediatric
patients, please refer to Appendix 3.

4.5.2. Spirometer
Spirometers must meet the minimum ATS/ERS recommendations which include
compliance with the International Organisation for Standardisation (ISO 26782)1
For information relating to testing equipment requirements when working with paediatric
patients, please refer to Appendix 3.

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For information relating to different types of flow-sensing spirometers, please refer to
Appendix 4.

4.5.3. Other supplies


Other supplies that are required for spirometry testing include:

• disposable/reusable supplies: mouthpieces, nose clips, flow sensors


(pneumotachometers)

• infection control supplies: disposable in-line bacteria filters, gloves, gowns, masks and
protective eyewear when indicated

• calibrated scales (standing and sitting) that measure to a weight of at least 300 kg

• calibrated stadiometer for measuring height and a tape measure for arm span
measurement. (For paediatric patients: Harpenden Callipers may also be required for
measurement of ulna length when standing height cannot be measured, refer to
Appendix 57)

• chair with arms, without wheels, preferably height adjustable for small adults and
paediatric chairs for paediatric patients

• computer/recorder supplies (depending on the type of spirometer used)

• barometer, thermometer and hygrometer, if not integrated into the equipment used.
This equipment is used for correcting volumes to body temperature (i.e. 37 0C),
ambient pressure, air saturated with water vapour (BTPS)

• validated 3 L-volume calibration syringe

• For bronchodilator responsiveness testing:

- metered dose inhaler (MDI) and spacer, or


- small volume nebuliser with compressed gas source and disposable nebuliser
mask/mouthpiece1.

4.6. Training requirements


Operator training in performing spirometry is required and the attainment and
maintenance of competency must be integrated in any spirometry testing service1.
There is evidence that within Australia the performance and quality of spirometry testing
is impacted by a lack of sufficiently trained staff, which leads to an inability to interpret
test results accurately as the testing has not aligned with international standards1, 8.
The QIP Accredited Queensland Health Spirometry Training Program is available to all
health professionals performing spirometry in Queensland.

For students and/or new staff commencing work within a TSANZ accredited respiratory
laboratory, training will be provided onsite. Other accredited spirometry training is also
available9 10.
For spirometry testing in preschool children, it is essential that the health practitioner
have the ability to establish rapport with the child, and that he or she is able to obtain
measurements without causing distress6.
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Additionally, when performing spirometry on a child, a Blue Card is required by staff who
are not registered health practitioners.

4.7. Test procedure


̵ Note:

• In paediatrics, the expressed ratio of FEV1 /FVC is used in preference to FEV1 /VC.

• Queensland Health recommends The Global Lung Initiative (GLI) 2012 reference
equations11.

4.7.1. Pre-test preparation


4.7.1.1. Preparing a spirometer
As outlined in the ATS Pulmonary Function Laboratory Management Manual: 12

• Assemble the components according to the manufacturer’s instructions (i.e. tubing,


connectors, flow-sensors, valves and adapters).

• Check the flow-sensors daily for holes, clogging, channel plugging, or excess moisture.
Refer to manufacturer’s guidelines if a problem is detected.

• Turn on the system to ensure adequate warm up (refer to manufacturer’s guidelines).


Allow time for equilibration to room temperature for portable systems.

• Document the environmental data from an accurate source representative of the


testing environment prior to calibration.

• Note: Environmental data includes internal spirometer temperature or ambient


temperature, relative humidity (if applicable) and barometric pressure.

• Perform a daily calibration and/or a calibration verification. (For detailed procedures


on performing calibration and/or a calibration verification see Appendix 6). Note:
More frequent checks may be required where there is high patient throughput.5

• Only perform spirometry at temperatures recommended by the equipment


manufacturer.

• Check recommended reference values are selected.

• Put in place a new in-line bacterial filter, disposable mouthpiece or disinfected


reusable mouthpiece for each patient.
4.7.1.2. Preparing the patient prior to the test

Ensure the patient has received education (written or verbal) regarding the necessary
preparation for effective testing conditions. Activities that should be avoided include1, 4 :
• smoking and/or vaping and/or water pipe use at least 1 hour before testing

• alcohol consumption at least 8hrs before testing

• vigorous exercise within 1 hour of testing

• wearing clothing that restricts chest and abdominal expansion

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If bronchodilator responsiveness testing is requested, notify patient prior to the testing
day about bronchodilator withholding times (See section 4.7.4).
Note: Inhaled corticosteroids and leukotriene modifiers need not be withheld.

Engage an interpreter if required as per Queensland Health Working with Interpreters


Guidelines 200713 .
4.7.1.3. Preparing the patient for the test

To prepare the patient for the test:

• Carry out infection control measures prior to testing, particularly hand washing or use
of an approved hand disinfection gel or wipe, for both patient and personnel
performing spirometry.

• For patients with confirmed or suspected transmissible infectious diseases extra


precautions must be taken. See Appendix 1 for further detailed information.

• Verify the following information:

- Check for completed and signed doctor’s request form, including indications and
contraindications to spirometry testing (see section 4.4 Indications and
Contraindications for performing spirometry)

- Confirm patient’s identity using at least three approved patient identifiers14 (e.g.
request the patient’s full name, address and date of birth and check the
procedure to be performed).

• Ensure the patient is wearing clothing that enables full chest and abdominal
expansion (if possible, loosen clothing).

• Assess patient for physical and developmental status to determine their ability to
perform the test and/or if special arrangements are required e.g. if the patient has a
tracheostomy.

• Record patient’s age in years (to one decimal place if the software allows).

• For individuals older than 25 years, where a reliable height measurement has been
made previously in the service, yearly height measurements are adequate1. For all
patients under the age of 25 years, height must be measured and recorded at each
visit. Measure and record height to the nearest 0.1 cm using an accurate and
validated measuring device (stadiometer). Refer to Appendix 5 for anthropometrical
measures for spirometry.

• Measure and record the patient’s weight in kilograms (kg) to the nearest 0.5 kg with
indoor clothing and without shoes. The weight is not required for most reference
values but may be useful for interpretative reasons.

• Record birth gender and gender identity. If needed, inform the patient that although
their gender identity is respected, it is their birth gender that is used to predict lung
size1 .

• Record ethnicity as this may affect the predicted lung size. Refer to Global Lung
Initiative (GLI) 2012 reference equations11 for correct classification and recording.

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• Record relevant medical history that may assist in the interpretation/reporting of the
spirometry. This may include the following:

- breathlessness, cough, sputum. wheeze, symptoms of asthma


- details relating to previous smoking/vaping/water pipe use
- known lung disease/chest injuries/operations
- work history and any occupational exposure to dust and respiratory irritants
- confirmation that the patient has ceased1, 4:
o smoking and/or vaping and/or water pipe use at least 1hr before testing

o alcohol consumption at least 8hrs before testing

o vigorous exercise within 1 hour of testing


- record current medication (type, dosage and time taken of any inhaled, oral or
injected medication) that may alter lung function and a brief history of use (as
outlined in section 4.7.4 Assessing bronchodilator responsiveness)
o document if the patient has withheld bronchodilator medications prior to
testing.

• Note: Instructions for withholding should be given to patients at the time of booking
an appointment.

• Note: The use of bronchodilator is at the patient and/or carer’s discretion despite the
recommendation to withhold before the test.

• Note: Refer to section 4.7.4 Assessing bronchodilator responsiveness for detailed


instructions regarding withholding times.

• Record testing position if not sitting and justification why test is performed in a non-
sitting position.

• In paediatric patient services, provide ample opportunity for the patient or carer to
ask questions or receive clarification on the test and its requirements. Young children
may not fully understand the requirements for the test but should be encouraged
enthusiastically.

4.7.2. Performing the test procedure


There are two methods for testing spirometry: open-circuit and closed-circuit.

In the open-circuit method the patient approaches the mouthpiece after a complete
inhalation to total lung capacity (TLC), whereas in the closed-circuit method the patient
inhales to TLC whilst firmly on the mouthpiece and after several tidal volume breaths on
the mouthpiece. Both methods are described below.
1. Introduce yourself to the patient, including your name and position title and establish
rapport.

2. Perform pre-testing zero-flow setting if recommended by the manufacturer. If


variable flow is detected during the zero flow setting procedure the procedure must
be repeated1.

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4.7.2.1. Performing the FVC and FEV1 manoeuvre1

1. Explain and demonstrate the test manoeuvre to the patient, including:


a) correct use of the mouthpiece and nose clip
b) correct posture with head and chin slightly elevated
c) position of the mouthpiece, including tight mouth seal over the
mouthpiece
d) the four distinct phases of the FVC manoeuvre:

- maximal inspiration
- a "blast” of expiration

- continued complete expiration

- if completing inspiratory loops, inspiration at maximal flow back to maximal


lung volume.

- Note: Phase 4 may be limited by the spirometry equipment, infection control


considerations, and in some patient populations e.g. young children).
2. Have the patient assume the correct sitting position i.e. upright posture, legs
uncrossed and both feet flat on the floor. To achieve this posture in children, it is
suggested that paediatric chairs are used.
3. Activate the spirometer:

a) When using the open circuit method:


- Attach the nose clip and instruct patient to inhale completely and rapidly
until their lungs are full, and within 2 seconds1 , place mouthpiece in mouth
and close lips tightly around the mouthpiece while holding their lungs full.
- Instruct patient to exhale forcefully until no more air can be expired.

b) When using the closed-circuit method:

- Attach nose clip, place mouthpiece in mouth (or assist patient in positioning
themselves on the mouthpiece) and instruct patient to close lips tightly
around the mouthpiece and breathe quietly for no more than 5 breaths (i.e.
relaxed, ‘normal’ tidal breathing).
- Instruct patient to inhale completely and rapidly until their lungs are full.

- With little or no pause at TLC (≤2 seconds 1 ), instruct patient to exhale


forcefully until no more air can be expired.
4. Encourage the patient to maintain an upright posture (i.e. no bending forwards)
during the manoeuvre.

5. If a flow-volume loop is being performed (to measure forced inspiratory vital capacity)
the patient will exhale rapidly and forcefully until end of test criteria are achieved,
and then inhale as rapidly as possible back to TLC.

6. Observe the patient at all times during the manoeuvre in case they become unsteady
due to light-headedness or experience other adverse reactions such as chest pain or
syncope.
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7. Terminate the manoeuvre (using keyboard, mouse or special function keys as
specified by the manufacturer) once the end of test criteria has been met (see section
4.7.3 Determining acceptability and repeatability).

8. Repeat the instructions and manoeuvres for a minimum of three acceptable


manoeuvres, more if necessary, coaching vigorously until end of test criteria are met;
no more than eight manoeuvres are usually required.

9. Terminate the test once the acceptability and repeatability criteria have been met
(see section 4.7.3 Determining acceptability and repeatability).
Note: The use of nose-clips is recommended even though they can sometimes
distract children.

Note: In paediatrics, the test procedure above should be adhered to with the
following exceptions:

- Correct posture with head slightly elevated for older children and in the
neutral position for younger children.
- More than eight manoeuvres can be attempted if necessary.

4.7.2.2.Performing the VC manoeuvre1

1. Explain and demonstrate the test manoeuvre to the patient, including:


a) correct use of the mouthpiece and nose clip
b) position of the mouthpiece, including tight mouth seal over the
mouthpiece
c) correct posture with head slightly elevated
d) slow, complete and relatively constant flow inhalation for VC
e) slow, complete and relatively constant flow exhalation for VC
f) emphasis on complete filling and emptying of the lungs.

Note: If requested by the medical officer, it is recommended that the VC is performed


before the FVC because of the potential for muscular fatigue and volume history
effects 5 .
Note: The Vital Capacity (VC) manoeuvre is not usually performed in paediatric
populations.

2. Have the patient assume correct posture and attach nose clip.
3. Activate the spirometer:
a) When using the open circuit method:

- Instruct the patient to inhale completely and rapidly until their lungs are full,
place the mouthpiece in the mouth and close lips tightly around the
mouthpiece while holding their lungs full.

- Instruct patient to exhale slowly and completely until their lungs are empty.

b) When using the closed-circuit method:


- Attach nose clip, place mouthpiece in mouth (or assist patient in positioning
themselves on the mouthpiece) and instruct patient to close lips tightly
around the mouthpiece and breathe quietly for no more than five breaths
(i.e. relaxed, ‘normal’ tidal breathing).
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- Instruct the patient to inhale completely until their lungs are full and exhale
slowly and completely until their lungs are empty. This provides a measure
of expiratory vital capacity (EVC).

- Alternatively, instruct the patient to exhale completely from end-inspiration


on a tidal breath until their lungs are empty. This provides a measure of
inspiratory vital capacity (IVC).

4. Encourage the patient to “keep going” until there is no volume change observed
(see section 4.7.3 Determining acceptability and repeatability).
5. Observe the patient at all times during the manoeuvre in case they experience
light-headedness or any other adverse reactions.
6. Terminate the manoeuvre (using keyboard, mouse or special function keys as
specified by the manufacturer) once the end of test criteria have been met (see
section 4.7.3 Determining acceptability and repeatability).
7. Repeat instructions and manoeuvres for a minimum of three manoeuvres,
coaching vigorously until end of test criteria are met; with a maximum of eight
attempts and a sufficient rest period between each manoeuvre1.
8. Terminate test once acceptability and repeatability criteria are met (see section
4.7.3 Determining acceptability and repeatability).
̵ Note: Some patients may not be able to use a standard mouth piece (for
example: patients with tracheostomy or nasal resection). The operator, at their
discretion, may try the use of facemasks, tubing connectors or occlusion valves
on these patients1

4.7.3. Determining acceptability, repeatability and useability criteria


of FEV1, FVC and VC measurements1
Clinically useful spirograms must be acceptable (i.e. meet the criteria that comprises a
good quality manoeuvre) and repeatable (i.e. the two highest FEV1, FVC and VC from
three acceptable manoeuvres are in close agreement).
A spirogram is “acceptable” if the following are met:

Start of test criteria

• Begins from full inspiration.

• Has a rapid start of test, that is, the back extrapolated volume (BEV) is <5% of FVC or <
0.100 L, whichever is greater (see Appendix 7). If the manoeuvre has an obviously
hesitant start the trial should be terminated early to avoid unnecessary prolonged
effort.

• No cough or glottic closure in the first second of expiration (affect FEV1).


For paediatrics (preschool children):

• The BEV ≤ 80ml and ≤ 10% to 12.5% of FVC6 15, then the curve is acceptable. 6. (More
rigorous criteria have been documented as acceptable: BEV ≤ 75 ml and ≤ 10% of
FVC)16. Note: curves not achieving this criterion should be reinspected, but need not
necessarily be excluded

Middle of test criteria


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No obstruction, hesitation or artefact impeding the blow (Appendix 8) including:

• Cough in the first second of expiration (affects FEV1).


• Glottic closure after the first second of expiration (affects FVC).

• Effort that is not maximal throughout.

• Air leaks at mouth.

• Obstructed mouthpiece (due to tongue or teeth in front of the mouthpiece, or


mouthpiece deformation due to biting).
End of Forced Expiration (EOFE)

Must achieve ONE of the following EOFE indicators

1. expiratory Plateau (≤0.025 L volume change for a one second period)


2. expiratory Time ≥15 seconds

3. max FVC is within the repeatability tolerance (≤0.150 L for patients >6 years of age;
≤0.100 L or 10 % of the highest value, whichever is greater for patients ≤ 6 years of
age) or greater than the largest prior observed FVC.

Note: EOFE 3) occurs when the patient cannot expire long enough to achieve a plateau
(for example: young children with high elastic recoil, patients with restrictive lung
disease or patient with neuromuscular disease).

If performing inspiratory loops, the forced inspiratory vital capacity (FIVC) should not
be larger than the FVC as this would indicate that the FVC has been underestimated
(FIVC minus FVC ≤0.100 L or 5% of FVC, whichever is greater)1
How to ensure repeatability between individual spirograms

After three acceptable spirograms have been obtained, the following checks are used to
assess for repeatability:

• For paediatric patients >6 years of age:


- The two largest values of FVC or VC must be within 0.150 L of each other.

- The two largest values of FEV1 must be within 0.150 L of each other.

• For paediatric patients ≤ 6 years of age:


- The two largest values of FVC or VC must be within 0.100 L of each other or 10%
of the largest FVC or VC.
- The two largest values of FEV1 must be within 0.100 L of each other or 10% of the
largest FEV1.
A minimum of three acceptable manoeuvres should be saved and utilised for
analysis/interpretation. If the repeatability criteria are not met in three manoeuvres, then
additional trials must be attempted. In adults up to eight manoeuvres can be safely
attempted and more in children.
Peak Expiratory Flow (PEF)

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During spirometry testing, PEF is measured in conjunction with FEV1 and FVC and can be
used to indicate maximal patient effort.
Note: PEF can also be measured independently using a Peak Flow Meter. Refer to ATS/ERS
guidelines5.

4.7.4. Assessing bronchodilator responsiveness1


Assessing bronchodilator responsiveness is performed as part of spirometry for initial
diagnostic reasons and ongoing asthma management. The choice of drug, dose and mode
of delivery is a clinical decision made by the medical officer requesting the test, and
dependent on the clinical question and clinical judgement.
Patient preparation

• Bronchodilator medications should be withheld prior to testing if evidence of


the presence or absence of reversible airflow limitation is required.
• Bronchodilator withholding times1:
- short-acting β-agonists (SABA) (e.g. Albuterol or Salbutamol): 4-6 hours

- short acting muscarinic antagonists (SAMA) (e.g. Ipratropium Bromide): 12 hours

- long-acting β-agonist (LABA)(eg. Formoterol or Salmeterol): 24 hours


- ultra Long-acting β-agonist (Ultra-LABA) (e.g. Indacaterol, Vilanterol, Olodaterol):
36 hours
- long acting muscarinic antagonists (LAMA) (e.g. Tiotropium, Umeclidinium,
Aclidinium or Glycopyrronium): 36-48 hours

- oral therapy with Aminophylline or slow release β agonist should be withheld for
12 hours 5 .

• If the aim of the test is to determine whether the patient’s lung function can
be improved with therapy in addition to their regular treatment, then regular
medication as prescribed can be continued.
Administration of bronchodilators

• A service requires a written protocol for administration of bronchodilators,


including choice, dose and mode of delivery. 1 Administration of
bronchodilators is governed by state legislation for individual health
professional groups and should be referred to when informing local practice17.
• The choice, dose and mode of delivery should be documented by the operator
in the technical comments of the report.
• Regardless of which method is used, consideration of pulmonary deposition
characteristics of the devices must be made so that appropriate and
standardised dosages are delivered. 5
• Salbutamol (Ventolin), the most commonly used bronchodilator, should be
administered using metered dose inhalation of 400 ug salbutamol (4 x 100 ug
metered doses) using a valved spacer device. 5
• Recommendation for administration of bronchodilators is as follows:

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- for pre-school children, via the tidal “normal” breathing method of five breaths
for every actuation
- for school age children and adults: via the breath-hold method of 5 -10 seconds
breath-hold following the actuation from the start of a rapid inhalation6 , after a
prior full exhalation.
Test procedure

• Perform spirometry according to section 4.7.2 Performing Test Procedure. This


will provide a ‘pre-bronchodilator’ spirometry result.
• Administer the bronchodilator medication in the dose and by the method
indicated for the test and according to local health service protocols and
procedures.
• Repeat spirometry according to section 4.7.2 Performing Test Procedure 10 to
15 minutes following administration for short-acting β-agonists, and 30
minutes for short acting anti-cholinergic agents 18. This will provide the ‘post-
bronchodilator’ result.

Acceptability, repeatability and interpretation 18

• Ensure test acceptability, repeatability and usability according to section 4.7.3


Determining acceptability and repeatability.
• A positive bronchodilator response is marked by significant responsiveness.
This is evident if there is:

- an increase in FEV1 and/or FVC of ≥12% compared with pre-bronchodilator


spirometry and
- ≥200 mL increase in FEV1 and/or FVC compared with a pre-bronchodilator
spirometry.

• For paediatrics - preschool children:


̵ The interpretation of responsiveness in children is subjective.
̵ The physician may look at the shape of the flow-volume curve
combined with the magnitude of improvement of FEV0.75. (or FEV0.5;
however, no GLI reference values are available for FEV0.5).
̵ An increase ≥12% in FEVt is usually taken as positive, however this
criterion is not well defined in pre-school children6.

4.7.5. Reporting results5


Reporting requirements include:

• All volumes and flows are to be reported at BTPS conditions.

• FEV1 and FVC should be reported in litres (L) to two decimal places.

• The largest FVC and largest FEV1from acceptable and repeatable manoeuvres are
reported, even though the values may not come from the same manoeuvre.

• The largest VC from at least two acceptable and repeatable manoeuvres is reported.

• The largest peak flow from an acceptable and repeatable manoeuvre should be
reported in litres per second (L/s) to two decimal places.
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• All other flows, if required by the requesting medical officer, are reported from the
“best” test. The “best” test is defined as the manoeuvre with the largest sum of FVC
and FEV1.

• If a single volume-time tracing or flow-volume curve is to be included in a final report,


it should be from the “best” test.

• Expiratory and inspiratory flow-volume curves from different acceptable efforts may
be combined to produce a flow-volume loop.

• The final report should include:


̵ patient identification and demographic information19

̵ scientist’s comments regarding acceptability, repeatability and usability of the


data

̵ software version (if applicable)

̵ date, time and results of most recent calibration


̵ identification of reference values used.
̵ reported values presented against the reference value for the parameter, the
percentage of reference and lower limits of normal (LLN). It is recommended the
Z-scores also be reported19.

• In paediatrics1, 6:
̵ GLI reference values for FEV0.75 are available for children aged 3-7 years of age
̵ for children aged 7 years or younger, FEV0.75 should be reported.

• Note: Test results that do not meet acceptability, repeatability and usability criteria
may still provide useful clinical information. It is important to make note of the
reasons in the report technical comments and advise to interpret with care.

4.8. Quality control procedures


Quality control procedures specific to spirometry testing are detailed in Appendix 6. Daily
calibration and/or calibration verification, weekly biological control testing, and data analysis are
the minimum quality control requirements.

5. Definitions
Term Definition / Explanation / Details Source
Acceptability Criteria Satisfactory start, middle and end of test conditions 5

Repeatability Criteria Closeness of agreement between the results of successive


measurements of the same item carried out, subject to all of
the following conditions: same method, same observer, same 5

instrument, same location, same conditions of use, and


repeated over a short space of time
BEV (L) Back extrapolated volume, litres (L) 1

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Term Definition / Explanation / Details Source
Equal to the volume of gas exhaled before time zero
BTPS Body temperature and pressure (saturated)
5
Body temperature (i.e. 37oC), ambient pressure, air saturated
with water vapour
EVC (L) Expiratory vital capacity, litres (L)
The maximal volume of air exhaled slowly from the point of 12

maximal inhalation
FEV1 (L) The forced expiratory volume in t seconds, litres (L)
12
The maximal volume of air expired by Time (t seconds) from
Time 0 of a forced expiratory manoeuvre.
FEV0.5 Forced expiratory volume in 0.5 second, litres (L)
1
The maximal volume of air exhaled in the first 0.5 seconds of
a forced expiration from a position of full inspiration
FEV0.75 Forced expiratory volume in 0.75 seconds, litres (L)
The maximal volume of air exhaled in the first 0.75 seconds 1

of a forced expiration from a position of full inspiration


FEV1/FVC (VC) The ratio of FEV1 to FVC (VC) 19

FVC (L) Forced Vital Capacity, litres (L)


The maximal volume of air exhaled from a forced expiration,
from a position of full inspiration (TLC)
FIVC (L) Forced Inspiratory Vital Capacity, litres (L)
The maximal volume of air inhaled with maximally forced 12

effort from a position of full expiration (RV)


IVC (L) Inspiratory vital capacity, litres (L)
The maximal volume of air inhaled slowly from the point of 12
maximal exhalation achieved by a slow expiration from end-
tidal inspiration
LABA Long-acting β-agonist
LAMA Long acting muscarinic antagonists
PEF (L/s) Peak expiratory flow litres per second (L/s)
The maximum expiratory flow achieved from a maximum 5
forced expiration, starting without hesitation from a point of
maximal lung inflation
PEFT Peak Expiratory Flow time in seconds (s)
16
The time to peak expiratory flow measured in seconds
QIP Quality Innovation Performance

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Term Definition / Explanation / Details Source
RV (L) Residual Volume, litres (L) 20
Volume of air remaining in the lungs after maximal expiration
SABA Short-acting β-agonists
SAMA Short acting muscarinic antagonists
TLC (L) Total lung capacity, litres (L)
21
The volume of gas in the lungs after maximal inspiration, or
the sum of all volume compartments
TV (L) Tidal volumes, litres (L)
The volume of gas inhaled or exhaled during the respiratory 21

cycle (also known as VT)


Ultra-LABA Ultra Long-acting β-agonist
VC (L) Vital capacity, litres (L)
The volume change between the position of full inspiration 12

and complete expiration


Standard units Litres (L)
Litres per second (L/s)
Litres per minute (L/min)

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6. Document approval details
Document custodian
Chief Allied Health Officer, Allied Health Professions Office of Queensland

Approval officer
Deputy Director General Clinical Excellence Queensland

Approval date: September 2021

Version control
Version Date Comments
1.0 2021 New document replaces previous guidelines Spirometry: adult
and Spirometry: paediatric. Guidelines condensed and updated
following the release of “Standardization of Spirometry 2019
Update. An Official American Thoracic Society and European
Respiratory Society Technical Statement” in 2019.

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Suggested readings and references
Suggested readings
1. Carl D. Mottram. 2013. Ruppel’s Manual of Pulmonary Function. 10th edition, Elselvier Mosby.
2. Johns DP and Pierce RP. 2007. Pocket Guide to Spirometry. 2nd edition, McGraw-Hill Australia.
3. Quanjer, PH. SpirXpert. ERS e-Learning Resourses. Available from: https://spirxpert.ers-
education.org/en/spirometry/welcome-to-spirxpert/

4. Rodwell L, McElrea M, Schneider I, Hopkins-Lincolne J, Hill D, Brown M. Culturally supportive


training for Indigenous Health Workers (IHWS). Respirology 2016:21(Suppl 2),19
5. Rodwell L, Schneider I, McElrea M, Brown M. A culturally appropriate indigenous spirometry
training program— a means to improve quantity and quality of spirometry performed in primary
care. Respirology (2018) 23 (Suppl. 1),17

Suggested resources
o For indigenous health workers within Queensland, there is an Indigenous Respiratory Outreach
Care (IROC) Spirometry training program

References
1. Graham, B.L., et al., Standardization of Spirometry 2019 Update. An Official American Thoracic
Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med, 2019.
200(8): p. e70-e88.
2. Queensland Health Informed decision making in health care. 2012.

3. National Health and Medical Research Council. Australian Guidelines for the Prevention and Control
of Infection in Healthcare. 2019 [cited 2020 23/06/2020]; CD33:[Available from:
https://nhmrc.govcms.gov.au/about-us/publications/australian-guidelines-prevention-and-control-
infection-healthcare-2019#block-views-block-file-attachments-content-block-1.
4. Miller, M.R., et al., General considerations for lung function testing. Eur Respir J, 2005. 26(1): p. 153-
61.

5. Miller, M.R., et al., Standardisation of spirometry. Eur Respir J, 2005. 26(2): p. 319-38.
6. Beydon, N., et al., An official American Thoracic Society/European Respiratory Society statement:
pulmonary function testing in preschool children. American Journal of Respiratory & Critical Care
Medicine, 2007. 175(12): p. 1304-45.
7. Gauld, L.M., et al., Height prediction from ulna length. Dev Med Child Neurol, 2004. 46(7): p. 475-80.

8. Monash Centre for Occupational and Environmental Health School of Public Health & Preventive
Medicine Faculty of Medicine, N.a.H.S.M.U., Review of Respiratory Component of the Coal Mine
Workers’ Health Scheme for the Queensland Department of Natural Resources and Mines. 2016,
Monash University & University of Illinois: Melbourne. p. 116.

9. Quality Innovation Performance Limited. Coal Mine Workers' Health Scheme. Spirometry Training
Course Provider Accreditation 2020 [cited 2020 26/02/2020]; Details regarding the accreditation
process for spirometry training courses]. Available from: https://www.qip.com.au/spirometry-
training-course-accreditation/.
Spirometry guideline – Queensland Health Guideline Page 18
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10. Swanney, M.P., et al., Spirometry training courses: Content, delivery and assessment - a position
statement from the Australian and New Zealand Society of Respiratory Science. Respirology, 2017.
22(7): p. 1430-1435.

11. Quanjer, P.H., et al., Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global
lung function 2012 equations. Eur Respir J, 2012. 40(6): p. 1324-43.
12. American Thoracic Society, Pulmonary Function Laboratory Management and Procedure Manual.
2nd ed, ed. J. Wanger, R. Crapo, and C. Irvin. 2005: American Thoracic Society.

13. Service, Q.H.I., Working with Interpreters Guidelines, Q. Health, Editor. 2007, Queensland Health
Electronic Publishing Service: Queensland. p. 38.

14. Australian Commission on Safety and Quality in Health Care Safety and Quality Improvement Guide
Standard 5: Patient Identification and Procedure Matching (October 2012). 2012, ACSQHC: Sydney.
15. Pesant, C., et al., Spirometric pulmonary function in 3- to 5-year-old children. Pediatric Pulmonology,
2007. 42(3): p. 263-71.

16. Enright, P.L., et al., Quality of spirometry test performance in children and adolescents : experience
in a large field study. Chest, 2000. 118(3): p. 665-71.

17. Allied Health Professions' Office of Queensland, Changes to scheduled medicine authorities –
Respiratory Scientists, Q. Health, Editor. 2018, Queensland Health: Queensland.
18. Pellegrino, R., et al., Interpretative strategies for lung function tests. Eur Respir J, 2005. 26(5): p. 948-
68.
19. Culver, B.H., et al., Recommendations for a Standardized Pulmonary Function Report. An Official
American Thoracic Society Technical Statement. Am J Respir Crit Care Med, 2017. 196(11): p. 1463-
1472.
20. Wanger, J., et al., Standardisation of the measurement of lung volumes. European Respiratory
Journal, 2005. 26(3): p. 511-22.

21. Wanger, J., et al., Standardisation of the measurement of lung volumes. Eur Respir J, 2005. 26(3): p.
511-22.

22. American Thoracic Society, Pulmonary Function Laboratory Management and Procedures Manual.
1st ed. 1994: American Thoracic Society.
23. Cotes, J.E., D.J. Chinn, and M.R. Miller, Lung Function Physiology, Measurement and Application in
Medicine. 6th ed. 2006: Blackwell Publishing.
24. Gauld, L.M., et al., Prediction of childhood pulmonary function using ulna length. Am J Respir Crit
Care Med, 2003. 168(7): p. 804-9.

25. Quanjer, P.H., et al., All-age relationship between arm span and height in different ethnic groups. Eur
Respir J, 2014. 44(4): p. 905-12.
26. Wainwright, C.E., et al., Cough-generated aerosols of Pseudomonas aeruginosa and other Gram-
negative bacteria from patients with cystic fibrosis. Thorax, 2009. 64(11): p. 926-31.
27. Johns, D. and R. Pierce, Pocket Guide to Spirometry. 2nd ed. 2007: McGraw-Hill Australia.

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Appendices
Appendix 1 – Infection control procedures
The aim of infection control is to provide a better understanding of infections and their modes of
transmission to staff. It is also important in maintaining a safe working environment for staff and
patients to help prevent disease transmission during lung function testing.
General hygiene guidelines
Poor hygiene practice not only increases patient morbidity but also increases patient mortality. Lung
function testing equipment can spread or transmit blood borne and airborne pathogens (droplets and
other particles containing microbes being released in the air) e.g. tuberculosis (TB), chicken pox
respiratory syncytial virus (RSV), human immunodeficiency virus, coronaviruses and hepatitis. The
majority of the patient population would not be affected but individuals who are immune-
compromised or have existing co-morbidities may develop complications 3 .
If an active respiratory infection has been identified in a patient, then the test request should be
confirmed with the requesting medical officer and align with local health service control procedures.
Transmission of pathogens1 4, 12
Transmission of pathogens can occur via several different routes including: patient - staff, staff–patient,
patient – patient, staff – staff, patient – equipment, and staff – equipment.
ATS/ERS guidelines 4 define direct and indirect contact with regards to pulmonary function testing and
transmission of pathogens as follows:

• Direct contact (from person to person):


̵ There is the potential for transmission of upper respiratory disease, enteric infections,
and blood-borne infections through direct contact. Although hepatitis and HIV
transmission are unlikely via saliva, disease transmission is a possibility when there are
open sores on the oral mucosa, bleeding gums, or haemoptysis.
• Indirect contact (via animate and inanimate objects):
̵ There is potential for transmission of TB, various viral infections, and possibly,
opportunistic infections, coronaviruses and nosocomial pneumonia through aerosol
droplets, generated by the patient blowing into the equipment or expelled into the air
of the testing room between manoeuvres.
̵ The most likely surfaces for contact are mouthpieces, noseclips, handheld spirometers,
chair arms, keyboards and other computer equipment, and immediate proximal
surfaces of valves or tubing.
̵ Common transmissible infectious diseases often seen in the Respiratory Laboratory
include:
 Hepatitis B
 Hepatitis C
 Tuberculosis (TB)
 Human Immunodeficiency Virus
 Burkholderia cepacia
 Pseudomonas aeruginosa
 Cytomegalovirus (CMV)
 Varicella Zoster Virus (VZV).
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Prevention and Precautions1 :

Standard precautions must always be followed. Disease prevention or cross contamination can be
prevented by considering the following infection prevention measures:

• ensure a clean environment according to local infection control guidelines


• proper hand-washing techniques or use of approved hand sanitisers:
̵ before contact with each new patient
̵ immediately after direct handling of mouthpieces, tubing, breathing valves, internal
surfaces of the spirometer and keyboards and mouse if used
• use of approved hand sanitisers by patients prior to testing and on completion of testing
• use of gloves in patients with contact precautions and a new pair for each patient
• use of gloves when handling contaminated equipment, where surfaces are suspected of
holding pathogens which could be potentially transmitted
• use of gloves by staff with open cuts or sores which need to be covered to prevent
contamination and or transmission of disease pathogens
• use of in-line bacterial/viral filters and/or disposable mouthpieces for all patients
• immediate disposal of all single use items such as filters, mouthpieces, noseclips, gloves and
spacers
• sterilisation and disinfection of reusable medical devices (RMDs) including valves and tubing
• use of and immediate disposal of personal protective equipment (e.g. gloves, gown, masks etc)
• isolation of susceptible patients (protective isolation) especially those at-risk e.g., patients with
cystic fibrosis or those who may be immuno-compromised
• implementing local infection control requirements that may supersede this document and
manufacturer’s requirements for at-risk populations.

Note: Disposable in-line filters:

• Single patient use disposable in-line filters integrated with mouthpieces are now standard
practice in many health care settings. They are an effective and less expensive method of
preventing equipment contamination.
• In-line filters have been shown to remove microorganisms from the expiratory air stream
and thus prevent their deposition as aerosol nuclei on spirometer surfaces.
• Many filters have a stated bacterial reduction efficiency of 99.7% at a flow rate of 750
L/min, i.e. they are designed for use during lung function testing with low resistance at
high flow rates yet retaining high filtration performance. That equates to a bi-directional
efficiency of 99.997%.
• The use of in-line filters does not eliminate the need for regular cleaning and
decontamination of lung function equipment.
• When using equipment with inspiratory and expiratory manoeuvres, in-line bacterial viral
filters must be used and disposed of after every patient (single patient use).

The ATS/ERS1 22 recommends extra precautions are taken for patients with known transmissible
infectious diseases:

• Reserve equipment for the sole purpose of testing infected patients.


• Test infected patients at the end of the day, allowing time for the equipment to be
dismantled and disinfected.

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• Test patients in their own rooms with adequate ventilation and appropriate protection for
the technician. A negative pressure air-conditioned room is ideal for this situation and aids
in the prevention of cross contamination.
• Place patients in a separate area apart from other patients, not in open waiting areas.
• Provide patients with surgical masks and instruct them to wear the masks.
• Provide patients with tissues and instructions on covering their mouth and nose when
coughing or sneezing.

Environmental engineering controls such as ventilation, air filtration or ultraviolet decontamination of


air should be used to help prevent disease transmission where spread is by droplet nuclei as seen in
tuberculosis.

The use of single patient use disposable in-line filters is strongly recommended for all spirometer types,
particularly as the accuracy of the spirometer could be affected by droplet deposition on flow sensors if
one-way valve mouthpieces are used

Cleaning and disinfecting procedures1, 3, 22:


• Manufacturer’s recommendations regarding the cleaning and disinfection of equipment must
be consulted in order not to cause damage with the wrong cleaning procedure. Heat
sterilisation or cold sterilisation chemicals can damage flow sensors, tubes and or seals.
• Manufacturers should describe the recommended chemicals and concentrations as well as the
PPE required by the staff undertaking the cleaning and disinfection procedure.
• Local Infection control requirements may supersede equipment manufacturers’ guidelines and
the ATS/ERS recommendations in at-risk populations so long as the equipment will not be
damaged by these procedures.
• Mouthpieces, nose clips and any other equipment coming into direct contact with mucosal
surfaces should be cleaned, disinfected, sterilized, or, if disposable, discarded after each use.
• Although the optimal frequency for disinfection or sterilization of tubing, valves, or manifolds
has not been established, any equipment surface showing visible condensation from expired
air should be disinfected or sterilised before reuse whenever the potential for cross
contamination exists.
• Exposed surfaces (for example, testing equipment, benches and chairs, keyboards and mouse)
in testing rooms should be cleaned thoroughly after each patient by adhering to local
procedures for routine environmental cleaning and transmission-based precautions3.

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Appendix 2 – Indications for performing spirometry1
Diagnostic indications:

• evaluate symptoms, signs or abnormal laboratory test results


• measure the effect of disease on pulmonary function
• screen individuals at risk of having pulmonary disease
• assess pre-operative risk
• assess prognosis.
Monitoring indications:

• assess response to therapeutic intervention


• monitor disease progression
• monitor patients for exacerbations of disease and recovery from exacerbations
• monitor people for adverse effects of exposure to injurious agents
• monitor for adverse reactions to drugs with known pulmonary toxicity.

Disability/impairment evaluations:

• assess patients as part of a rehabilitation program


• assess risks as part of an insurance evaluation
• assess individuals for legal reasons.
Other:

• research and clinical trials


• epidemiological surveys
• derivation of reference equations
• derivation of reference values
• pre-employment and lung health monitoring for at-risk occupations
• assess health status before beginning at-risk physical activities.

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Appendix 3 – Facilities and equipment – considerations for paediatric patients
Testing facilities

• A child friendly pulmonary function laboratory is of the utmost importance. Young children
need to feel comfortable in the laboratory environment if they are to perform spirometry well.
The operator has a significant impact on the comfort level of the child 6. This type of
environment may be achieved through a combination of friendly conversation, songs, or
through distraction with a videotape, book, interactive computer game, toy or puzzle.
• Designated rooms may help to prevent distraction in children during testing.
• Ensure clearly defined rooms are available for spirometry testing, particularly for patients with
confirmed or suspected communicable diseases, and immuno-compromised patients. Specific
infection control procedures pertaining to spirometry testing are outlined in Appendix 1.
• Allow adequate space for chairs, wheelchairs, and prams for the child and accompanying
adult(s), and accommodation for staff who may require mobility assistance.
Spirometer

• Ensure the spirometer’s graphic display permits visual inspection of the flow–volume and
volume–time curves essential for quality control. Preschool children are less likely to produce
technically adequate expirations than older children and are likely to become bored or tired if
the test session is prolonged unnecessarily. It is therefore advantageous if the operator and the
child can visualize these curves onscreen, or at least before the next effort.
• Set the display to include FVC, FEVt, time to PEF (PEFT), BEV (back-extrapolation volume) and
the point at which flow ceases, presented as a proportion of PEF. Timed volumes displayed for
pre-schoolers should include FEV0.5 or FEV0.75 and FEV1. Review these measurements before the
next effort and encourage the child to alter his or her technique if necessary 6.
• Paediatric spirometry software equipment may include animated incentives intended for both
pre-schoolers and older children. These incentives are designed to encourage rapid and
prolonged expiration 6. Incentives that encourage tidal breathing and maximal inspiration may
also be helpful. Use these visual incentives discretionally as they may distract some children.
• Spirometers for use in preschool patients must be capable of measuring instantaneous flows
with an accuracy of at least ± 5% 6. Dead space should be minimized where possible, although
this requirement does not preclude the use of bacterial filters. Otherwise, recommendations
for equipment for use in adult subjects apply6.

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Appendix 4: Flow-sensing spirometer types
The flow-sensing spirometer measures air flow rate directly. The volume is then derived electronically
from the flow signal. There are several different types:

1. The pneumotachometer measures flow by using a differential pressure flow sensor, which consists of
a tube containing a resistive element. The resistive element allows gas to flow through it but
causes a pressure drop. The pressure drop across the resistive element is measured by means of a
sensitive pressure transducer, with pressure taps on either side of the element, and is proportional
to the flow rate of gas if the flow is laminar (not turbulent). In some systems the resistive element
is heated, which prevents accumulation of moisture from exhaled gas on the element.

2. The ultrasonic flow sensor measures flow using ultrasonic pulses travelling in opposite directions at
an angle to the air flow. The speed at which the pulses travel is dependent on the air flow rate and
direction and can be determined from the time the pulses take to travel from one side to the
other. The flow rate is thus determined from the pulse transit times.
3. The hot-wire flow sensor (anemometer, mass-flow sensor) contains a heated wire (or wires). As air
flows past the wire it is cooled, with the degree of cooling dependent on the air flow rate. The air
flow rate is proportional to the amount of electrical current required to keep the wire heated,
which depends on the mass of air flowing over the wire.
4. The rotating vane flow sensor (turbine type) has a very light vane which spins when air flows past.
The rotating vane interrupts the light path between a light source and photocell, causing pulses at
the photocell. The air flow rate is proportional to frequency of these pulses.

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Appendix 5: Anthropometrical measures for spirometry
Measurement of standing height – Frankfort horizontal plane23

The measurement is made using a stadiometer, leaving both hands free to position the subject whilst
measuring height. Measure and record the patient’s height (barefoot) in centimetres (to the nearest
0.1 cm), without shoes, feet together, heels against the wall, standing as tall and straight as possible
and with the head in the Frankfort horizontal plane: 23

• Instruct patient to place heels together and stand as tall as possible with the heels, calf,
buttocks and back preferably touching the stadiometer.
• Once the patient is in this position cup the angles of the mandible in both hands, tilt the
patient’s face so that the lower orbital margin (eye socket) is level with the external auditory
meatus (ear canal). This is the Frankfort Plane (see Figure 1).
• Gently apply upward lifting pressure to the mastoid processes, to elongate the vertebral
column.
• If measuring a child, instruct the child to inhale deeply, and “stretch tall” whilst the
measurement is made.
• Measure and record the height to the nearest centimetre in adults and 1 millimetre in children.
Note: Compared with subjects who are standing erect but unsupported this procedure can
increase the apparent height by up to 5 cm. It can also eliminate diurnal variation and improve
the reproducibility, which is then less than 2 mm. Note: In paediatric patients, where accurate
height measurements are not able to be obtained (e.g. scoliosis), then ulna length should be
measured using Harpenden callipers7, and the estimated standing height then used in
pulmonary function prediction equations (see below)24, 25

Figure 1. Measurement of stature showing the effects of moving the head into the Frankfort plane (short dashed line at eye level), and
then applying traction. The same method is also used for accurate height measurement in adults. (Diagram supplied courtesy of Barry
Dean, Queensland Children's Respiratory Centre, Royal Children's Hospital, Herston QLD, 4029).

Measurement of ulna length and its use in estimating standing height and predicting lung function

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To measure the length of the ulna bone, it is necessary to use a measurement instrument such as
Harpenden Callipers. Ulna length typically ranges from 15 to 30 cm in children.

• The ulna length is obtained by seating the child with the forearm resting comfortably on a flat
surface. Place the palm downwards with the fingers extended and together. The elbow is bent
at 90o to 110o. The proximal end of the ulna is found by palpating along its length. The tip of the
styloid process is felt at the wrist (Figure 2) by palpating down the length of the bone distally
until its end is felt. The tips of the anthropometer (Harpenden Calliper) are placed adjacent to
both end points, and the ulna length(U) is measured in cm to one decimal place (Figure 3).
• Use in calculating standing height: standing height can be estimated from measured ulna
length (U) using the equations of Gauld7. The estimated height can then be used to predict FEV1
and FVC based on current recommended GLI reference equations11.
• Use in predicting lung function: Having measured the ulna length (U), a prediction of FEV1,
FVC and FEF25-75% can be based on the published reference values and equations of Gauld24.

Figure 2. Position of Ulna Styloid process


Figure 3. Using Harpenden callipers to measure ulna length7

Measurement of arm span 23


• For patients unable to stand upright, (or if ulna length is not able to be measured in children),
arm span should be measured as it closely approximates standing height25:
̵ Have the patient stretch their arms in opposite directions (adducted at 90o) with the
elbows and wrists extended and the palms facing directly forward.
̵ Using a tape measure, measure to the tip of one middle finger to a point at the centre
of the spine, then measure from the same point to the tip of the other middle finger.
̵ Add these two measurements together to record arm span measurement.
̵ Use this downloadable calculator to assist calculate the corresponding standing height.

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Appendix 6 – Quality control procedures5
Quality control must be conducted to ensure the precision and accuracy of the test equipment, test
procedures and the results collected. It includes the regular maintenance and calibration of equipment
and the regular testing of biological controls to validate testing equipment and test procedures. All
results of quality control testing should be recorded and analysed so that any problems can be
identified and rectified as soon as they arise. Quality control processes that conform to a “best practice
model” are outlined below. 12
Instrument maintenance

1. Regular preventative maintenance (PM) must be performed by the operator to anticipate


problems with the spirometer and related equipment before they occur. The frequency of PM
as outlined by the equipment manufacturer and the ATS/ERS guidelines should be followed1.
PM should include regular inspection of spirometer tubing, connectors and electrical cords and
plugs.
2. Corrective measures may include unscheduled action required to correct the instrument’s
failure and can be performed by the manufacturer, hospital bioengineer or the operating staff.
3. Maintenance logs must be kept and include dates and types of tasks conducted along with
instructions on what action is to be taken if a problem is identified and needs to be rectified. At
a minimum the following record should be kept:
a) problem or troubleshooting log
b) preventative maintenance list/log
c) calibration log
d) quality control log
4. New instrumentation verification must be performed on all new equipment before patient
testing begins.
Instrument calibration

To have confidence in the data that is generated during spirometry testing, the spirometer must be
regularly validated for volume and linearity. Depending on the type of spirometer used, these
parameters need regular calibration, whereas some only require calibration verification.

Calibration syringe 12

• The calibration syringe should be stored at the same temperature and humidity as the testing site,
away from direct sunlight and heat sources. This is best achieved by storing the syringe close to
the spirometer. Holding the syringe body to steady it during calibration can raise its temperature
and contribute to measurement error.

• A calibration syringe should be used to check the volume calibration of spirometers and must
have an accuracy of ±15mL or 0.5% of the full scale, whichever is greater. For most spirometers
the syringe volume required is 3L.

• A calibration syringe should be validated yearly to ensure accuracy. For specific details refer to the
manufacturer’s recommendations.

• A calibration syringe should be checked monthly for leaks by attempting to empty it with the
outlet occluded. This should be performed at more than one volume.

• Perform regular inspection of adjustable or variable stops, if they exist. A dropped or damaged
syringe should be considered out of calibration until it is checked.
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• Use of the syringe on many machines distinguishes between instrument problems and problems
with the syringe.

Procedure for calibration5

• Calibration is the procedure for establishing the relationship between the flow or volume
measured by the sensor and the actual flow or volume of the calibration syringe.

• Volume calibration should be performed at least daily, or after every 10 patients in a busy
service. 2

• Recalibration may be indicated and BTPS correction factors updated if the testing environment
temperature changes. 4

• In-line bacterial-viral respiratory filters must be in place during calibration if they are used during
testing. 5

• Some portable spirometers are calibrated by the manufacturer and only require a daily calibration
verification (also known as calibration check, calibration verification). Check manufacturer’s
guidelines.

• A new calibration or equipment maintenance by the manufacturer is required if a device fails its
calibration verification. Check manufacturer’s guidelines for trouble shooting advice.

Calibration verification

• Calibration verification ensures that the spirometer is within calibration limits (+/-3% of the true
volume, 3 L where a 3 L syringe is used; +/-2.5% for the spirometer and +/-0.5% for calibration
syringes 1 ).

• Calibration verification should be performed at least daily or after each calibration or after every
10 patients in a busy service. 2

• Re-verification may be indicated and BTPS correction factors updated if the testing environment
temperature changes. 4

• In-line bacterial-viral respiratory filters must be in place during the calibration verification if they
are used during testing. 5
Procedure for calibration verification 5

• Perform calibration verification at least daily with a 3L syringe. Check manufacturer’s guidelines for
details.
• A 3.00 L syringe should be injected at three different flow rates between 2 and 12 L/s (with 3 L
injection times of ~6 second and < 0.5 second); minimum volume accuracy should be within 3% at
all flows.
• For spirometers that use disposable flow sensors, a new unused sensor should be tested daily.
• A flow linearity check of pneumotachs weekly ensures that minimum volume accuracy is met for
the entire range of flows measured (low-, mid-, high-flows). If the spirometer meets volume
accuracy requirements of ±3% for all flow rates tested then it meets the requirements for linearity.

Quality control analysis


Data from calibrations and other quality control procedures must be analysed regularly to be useful
and contribute to quality assurance procedures. The results analysed must be obtained in a stable

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laboratory environment using the same calibration syringe, calibration/calibration verification
procedure, biological standard or control material (e.g. 3 L syringe).
Biological control characterisation

A biological control is a healthy, non-smoking individual, usually a staff member, that is regularly tested
and becomes the reference standard for the biological control program. A biological control procedure
does not replace regular syringe calibration and calibration verification procedure. Biological control
testing is a requirement for occupation health screening for the Coal Mine Workers Health Scheme
(CMWHS). It is recommended to have more than one biological control.
Biological controls must initially be “characterised” according to the “gold standard” testing procedures
before the data becomes the “reference standard”. The biological control’s lung function must be
measured as accurately as possible under ideal conditions to determine a baseline value. All
subsequent testing of the biological control is compared to this baseline value. Characterisation
determines the variability of the biological control under the most ideal conditions. As normal lung
function deteriorates with age, it is important to check biological data periodically.
Characterisation requires that:

• FEV1, VC, FVC volumes are measured according to ATS/ERS guidelines for acceptability and
repeatability. 1, 5
• The subject is free of symptoms or known respiratory disease that may cause variability in lung
function results.
• Data is collected at least 10 times over a 1 to 2 week period under the above conditions to assess
variability of the individual’s data.
• The mean for each measured parameter becomes the reference standard or the “correct value”.
Biological control data analysis

Day to day variations in physiological function of the biological control occur even under ideal testing
conditions. The variability is used to set the “control limits for the test”, and allows identification of
data that is “out of control”, and is determined by the following steps:

• record FEV1 , FVC, VC for the 10 or more test manoeuvres performed

• for each parameter measured calculate mean and standard deviation

• the mean value during gold standard testing is the “correct value” for the biological control

• the standard deviation can now be used to set the control limits, where mean ± 1.96 x SD gives a
confidence interval of 95%, this means that approximately 95% of the values will be between ±
2SD of the mean

• The biological control results, collected on a regular basis, can be plotted on a Levy-Jennings plot
(see Graph 1) and interpreted using the Westgard rules. Westgard rules can be used to define
specific limits for biological control results when compared with the “gold standard” testing
results and to help determine if quality assurance responses need to be enacted, as follows: 12
̵ when one control observation exceeds the mean ±2 SD, a "warning" condition exists

̵ when one control observation exceeds the mean ±3 SD, an "out of control" condition exists

̵ when two consecutive control observations exceed ±2 SD, an "out of control" condition exists

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̵ when four consecutive control observations exceed the mean ±1 SD in the same direction, an
"out of control" condition exist
̵ when 10 consecutive control observations fall on the same side of the mean, an "out of
control" condition exists

̵ generally, the following rules apply:


 the ±2 SD limits are considered warning limits

 values between 2 and 3 SD limits indicate an error and the procedure should be repeated

 values beyond ±3 SD are considered unacceptable and the testing system should be
evaluated.

Biological control testing procedure

• Routine biological control testing is performed weekly.


• Routine biological control testing is performed under the same condition as routine patient testing
according to ATS/ERS guidelines. 5
• Graph the biological control result on a Levy-Jennings Plot (see Graph 1), which has horizontal lines
running across it to indicate the mean, as well as one, two and sometimes three standard
deviations either side of the mean (derived from the characterisation of the biological control).
These provide visual feedback of whether control values are “in” or “out of control”.
• Westgard rules are then used to determine if any quality assurance procedures need to be enacted.

Figure 4. Example of a Levy-Jennings plot showing


the mean (blue line) and one (green lines) and two
standard deviations (red lines) derived from
biological control characterisation. The
observation points are VC results obtained from a
biological control. In this example, no quality
assurance procedures need to be enacted.

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Appendix 7 – Determination of back-extrapolation volume (BEV)
Most computerised systems provide immediate feedback on back-extrapolation volume and should be
used by the operator to determine if this acceptability criterion has been met.

To determine the back-extrapolation volume a line is constructed through the steepest part of the
volume–time curve (Figure 1). Where this line crosses the time axis is the new “time zero”, from which
all timed volumes (such as FEV1 ) are measured. The back-extrapolation volume is the volume on the
spirogram at the new “time zero”. To render a spirogram acceptable the back-extrapolation volume
must be less than 5% of the FVC or 0.100 L, whichever is greater1 .

Figure 5. An expanded version of the early part of a volume-time spirogram, with a back-extrapolation line through the steepest part of
the curve to determine the new time zero at ~ 0.21 seconds. The back-extrapolation volume is 0.09 L (determined by volume expired at
new time zero). If the FVC is 4.18 L then EV is 2.1% FVC. 5, 22

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Appendix 8 – Examples of unacceptable volume-time and flow-volume
spirograms

Figure 6. Examples of unacceptable volume-time spirometry results compared with good efforts 26

Figure 7. Examples of unacceptable flow-volume spirometry loops compared with an acceptable effort 27

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