Effect of High-Frequency Oral Airway and Chest Wall

Oscillation and Conventional Chest Physical Therapy

on Expectoration in Patients With Stable Cystic
Fibrosis*
Thomas A. Scherer, MD, FCCP† Jürg Barandun, MD;† Elena Martinez, R-CPT;
Adam Wanner MD, FCCP; and Eben M. Rubin MD, FCCP

Study objective: To compare the effect of high-frequency oral airway oscillation, high-frequency
chest wall oscillation, and conventional chest physical therapy (CPT) on weight of expectorated
sputum, pulmonary function, and oxygen saturation in outpatients with stable cystic fibrosis (CF).
Design: Prospective randomized trial.
Setting: Pediatric pulmonary division of a tertiary care center.
Patients: Fourteen outpatients with stable CF recruited from the CF center.
Interventions: Two modes of oral airway oscillation (1: frequency 8 Hz; inspiratory to expiratory [I:E]
ratio 9:1; 2: frequency 14 Hz; I:E ratio 8:1), two modes of chest wall oscillation (1: frequency 3 Hz; I:E
ratio 4:1; 2: frequency 16 Hz; I:E ratio 1:1, alternating with frequency 1.5 Hz, I:E ratio 6:1), and CPT
(clapping, vibration, postural drainage, and encouraged coughing) were applied during the first 20
min of 4 consecutive hours.
Measurements and results: Sputum was collected on an hourly basis for a total of 6 consecutive hours.
During the first and the last hour, patients collected sputum without having any treatment and
underwent pulmonary function tests (PFTs). Oxygen saturation was measured at 30-min intervals
during hours 1 to 6. For the first 20 min of the second to the fifth hour, patients received one of the
treatments. To assess the effect of the intervention, the weight of expectorated sputum during hours
2 to 6 was averaged and expressed as percentage of the weight expectorated during the first hour
(baseline). For the five treatment modalities, mean sputum dry and wet weights ranged between
122% and 185% of baseline. There was no statistically significant difference among the treatment
modalities. As measured by sputum wet weight, all oscillatory devices tended to be less effective than
CPT (p50.15). As measured by dry weight, oral airway oscillation at 8 Hz with an I:E ratio of 9:1 and
CPT tended to be more effective than the other treatment modalities (p50.57). None of the treatment
modalities had an effect on PFTs and oxygen saturation and all were well tolerated.
Conclusion: In outpatients with stable CF, high-frequency oscillation applied via the airway opening
or via the chest wall and CPT have comparable augmenting effects on expectorated sputum weight
without changing PFTs or oxygen saturation. In contrast to CPT, high-frequency oral airway and
chest wall oscillations are self-administered, thereby containing health-care expenses.
(CHEST 1998; 113:1019-27)

Key words: chest physical therapy; cystic fibrosis; high-frequency oscillation; mucus clearance
Abbreviations: CF5cystic fibrosis; CPT5chest physical therapy; f5frequency; Fmaxe5peak expiratory flow; Fmaxi5peak
inspiratory flow; FRC5functional residual capacity; HayOp5Hayek Oscillator used at “optimum” settings; HaySe5Hayek
Oscillator used in “secretion clearance mode;” I:E5inspiratory to expiratory; MCT15treatment with the Sensormedics MCT
1 oral airway oscillator; OCI5oscillatory clearance index; O2 sat5oxygen saturation; PFT5pulmonary function test;
rhDNAse5recombinant human DNAse; SenB5treatment with the Sensormedics 3100B ventilator; Te5duration of
expiratory airway wall displacement; Ti5duration of inspiratory radial airway wall displacement

*From the Division of Pulmonary Diseases (Drs. Scherer, Barandun,

Wanner, and Rubin), and Division of Pediatric Pulmonary Diseases
(Ms. Martinez), University of Miami School of Medicine.
†
Currently at the Pulmonary Division, Triemli City Hospital,
Zürich, Switzerland (Dr. Scherer), and Director and Chief
Physician, Zürcher Höhenklinik, Davos-Clavadel, Switzerland
(Dr. Barandun).
This work was supported by grants from Sensormedics Corporation,
Yorba Linda, Calif, and from Respironics Inc, Murraysville, Pa.
Manuscript received December 9, 1996; revision accepted Au-
gust 12, 1997.
I nsecretions
subjects with normal lungs, tracheobronchial
are cleared by mucociliary transport.
This airway clearance system fails in patients with
chronic bronchitis, bronchiectasis, and cystic fibrosis
(CF).1 Because accumulation of mucus in the lower
airways may contribute to chronic infections that
lead to progressive deterioration in lung function,
clearing of airway secretions by chest physiotherapy
(CPT) forms an integral part of the treatment of

CHEST / 113 / 4 / APRIL, 1998 1019

patients with CF. Previous studies have shown that
regular CPT is able to enhance expectoration2-8 and
to slow deterioration of lung function.9,10
Recently, new methods have been developed to
help clear excessive airway mucus. Among them are
high-frequency oral airway oscillation and high-
frequency chest wall oscillation.11-16 Previous studies
have suggested that treatment with chest wall oscil-
lation is as effective as conventional CPT in patients
with CF.17-20
According to earlier experiments, prerequisites for
optimal transport of mucus by air-liquid interaction
in a cephalad direction include airflow with an
expiratory bias,11,14,16,21 which needs to be in the
range of 1 to 3 L/s,16,22 and for oral airway oscillation,
an oscillation frequency between 8 and 15 Hz.11,15,21
Based on these findings and on the results of pre-
liminary studies with both an airway and a chest wall
oscillator, we determined the settings for several
devices that we considered optimal for mucus trans-
port. Together with an airway oscillator at its manu-
facturer-provided operational mode and a manufac-
turer-provided secretion clearance program for the
chest wall oscillator, we used our theoretically opti-
mal treatment modes for the airway and chest wall
oscillators. The aim of the study was to test if
oscillations applied to the oral airway opening and to
the chest wall are as effective as CPT in increasing
the weight of expectorated sputum in patients with
stable CF, and if treatment with the oscillatory
devices is as well tolerated as CPT.
Materials and Methods
All patients were recruited from the CF Center at the Univer-
sity of Miami. A diagnosis of CF was confirmed by sweat test, and
all had increased sputum production. The protocol was approved
by the ethics committee, and the patients or their guardians gave
written informed consent prior to being enrolled in the study.
Selection Criteria
Inclusion Criteria: Inclusion criteria were diagnosis of CF,
stable condition for at least 3 weeks prior to enrollment, and age
12 years or older.
Exclusion Criteria: Exclusion criteria were major hemoptysis
(.240 mL) within the last month, pneumothorax or chest tube
placement within the last 6 months, and pregnancy. Treatment
with mucoactive drugs, including recombinant human DNAse
(rhDNAse), was not an exclusion criterion.
Exit Criteria: Exit criteria were on request by the patient or his
or her guardian, on completion of the study, intolerance of the
treatment, or developing one of the exclusion criteria.
Mechanical Devices
Three advanced mechanical oscillatory devices were used:
Sensormedics 3100B Oscillatory Ventilator, the MCT1 oscillator
1020
(both from Sensormedics Corporation; Yorba Linda, Calif), and
the Hayek Oscillator (Breasy Medical; Stamford, Conn).
The 3100B oscillatory ventilator is a commercially available
electronically controlled oral ventilator, using a servo-controlled
piston and a compressed gas supply. It is active in both inspira-
tory and expiratory phases, and is capable of a wide range of
adjustment, particularly for inspiratory to expiratory (I:E) ratio
and frequency.
The MCT1 is an oral airway oscillator using an electronically
servo-controlled piston. This device was designed to aid mucus
clearance. It delivers oscillations via a mouthpiece at a fixed I:E
ratio of 8:1 and a variable rate and drive power.
The Hayek Oscillator is a chest cuirass ventilator designed to
deliver high-frequency oscillations to the chest wall. A dual pump
system generates positive and negative pressures that are con-
ducted to the cuirass via flexible tubing. By electronic control of
the pump, a range of I:E ratios, frequencies, cuirass pressures,
and effective functional residual capacities (FRCs) can be set.
Additionally, a programmed “secretion clearance mode” is pro-
vided. This consists of alternating applications of oscillations (16
Hz, I:E ratio 1:1, for 2 min, and 1.5 Hz, I:E ratio 6:1, pressure
span 215/110 mm Hg for 3 min).
The Oscillatory Clearance Index
Based on theoretical considerations and on results of previous
experiments, we derived an empiric oscillatory clearance index
(OCI) that includes the frequency of the oscillations (f), peak
inspiratory and expiratory flows (Fmaxi and Fmaxe), and the
duration of inspiratory and expiratory airway wall displacement
(Ti and Te):
OCI5@f[Hz]3~Fmaxe/Te!/~Fmaxi/Ti!#2f
Based on this theoretical index, preliminary experiments were
conducted to find out optimal settings for the oral airway and the
chest wall oscillator to transport mucus in a cephalad direction.
Determining the Optimal OCI With the Oral Airway Oscillator
Using the Sensormedics Oscillatory Ventilator 3100B, we
calculated the OCI for different settings. The airway oscillations
were applied to the airway opening via a mouthpiece. Airflow was
measured with a pneumotachograph (Rudolph 4813; Kansas
City, Mo) at the airway opening, and change in neck circumfer-
ence as a measure of radial airway wall displacement was
measured with a respiratory inductive plethysmograph, modified
to remove the low-pass filter (Respitrak; Non-Invasive Monitor-
ing Systems; Miami Beach, Fla). To prevent oscillations of the
cheeks, a clamping device applied constant pressure to the
cheeks. An occlusive noseclip was also fitted. Measurements were
taken with subjects comfortably seated while breath-holding at
FRC position for 5 to 10 s. The data were recorded with a model
78D polygraph (Grass Instruments; Quincy, Mass) and manually
analyzed.
Twelve normal adults and six adult patients with COPD, whose
conditions were diagnosed according to the American Thoracic
Society guidelines,23 were examined. In normal subjects, the
highest OCI of 61 was attained with a frequency of 12 Hz and an
I:E ratio of 9:1. In COPD patients, the highest OCI reached was
28 with a frequency of 8 Hz and an I:E ratio of 9:1.24
Determining the Optimal OCI by High-frequency Chest Wall
Compression
Chest wall compressions were applied with the Hayek Oscil-
lator. The airflow at the airway opening was measured with the
Clinical Investigations
pneumotachograph, attached to a mouthpiece, and radial airway
wall displacement was measured with respiratory inductive pleth-
ysmography by attaching a band around the midchest. A noseclip
and the cheek stabilization device were fitted. Measurements
were taken with subjects comfortably seated while breath-hold-
ing at FRC position for 5 to 10 s. The data were directly fed into
a personal computer via an analog to digital converter board and
analyzed using custom-made software.
The OCI was determined for multiple machine settings in 10
normal adults and 5 patients with COPD. To reach airflows in the
range of 2 L/s, we had to set the chamber pressures of the cuirass
at 210 and 110 mm Hg during inspiration and expiration,
respectively. Due to limitations of the hardware, at frequencies
above 4 Hz, I:E ratios higher than 4:1 could not be attained. The
highest OCI reached was 12 in normal subjects and 7 in COPD
patients with an I:E ratio of 4:1, a frequency of 3 Hz, and cuirass
pressures of 610 mm Hg.
Based on these results and assuming that all our patients had
chronic airflow obstruction, we chose as study settings the ones
that resulted in the highest device-specific OCI in COPD
patients.
Randomization
The study contained five treatment arms. One treatment mode
was applied per study day (in the afternoon), with a minimal
interval of 2 days between study days. Randomization was
performed with a computer-generated randomization table.
Treatment Arms
1. “SenB”: High-frequency oral airway oscillations with the
Sensormedics Oscillatory Ventilator 3100B were applied at an I:E
ratio of 9:1, a frequency of 8 Hz, and a positive end-expiratory
pressure of up to 4 mm Hg if tolerated. The power (oscillatory
tidal volume) was increased to the extent that vibrations could be
felt through the chest wall. The cheek compression device and a
noseclip were used during treatments. In 5-min intervals, the
patients were positioned supine, then left and right lateral
decubitus, and again supine (total of 20 min).
2. “MCT1”: Treatment with the Sensormedics MCT1 oral
airway oscillator was given at an I:E ratio of 8:1 and a frequency
of 14 Hz. The positive end-expiratory pressure was increased
with an expiratory valve to an extent that patients felt some
expiratory resistance but were still able to breathe comfortably.
The power setting, cheek support, noseclip, and body positioning
were similar to SenB.
3. “HayOp”: High-frequency chest wall compression with the
Hayek Oscillator was carried out at an I:E ratio of 4:1 and a
frequency of 3 Hz. The cuirass pressure was set to 210 mm Hg
during inspiration and 110 mm Hg during expiration. Due to the
bulky cuirass, comfortable lateral positions were not possible.
Therefore, the patients remained in supine position during
treatments. The patients’ cheeks were not supported and no
nose-clip was fitted.
4. “HaySe”: High-frequency chest wall compression with the
Hayek Oscillator was performed using the program settings
provided by the manufacturer for secretion clearance. It con-
sisted of vibrations at 16 Hz during 2 min (16 Hz, I:E ratio 1:1)
alternating with chest wall oscillations during 3 min (1.5 Hz, I:E
ratio 6:1, pressure span of 215 mm Hg/110 mm Hg during
inspiration and expiration, respectively). Patients remained in a
supine position while receiving treatments, the cheeks were not
supported, and no noseclip was fitted.
5. “CPT”: Conventional CPT consisted of postural drainage
(head-down tilt 30°), clapping, external vibration with a standard
electrical chest wall percussor (frequency 40 Hz), and encour-
aged coughing.
Protocol
All patients were allowed to continue treatment with their
medications, except for inhaled b2-adrenergic agonists, which
were not permitted 4 h prior to and during the treatments.
During the time of enrollment, patients received only the
study treatments, unless the interval between treatments was
.5 days.
On study days, the patients arrived at the laboratory around
noon. Baseline pulmonary function tests (PFTs) were performed
with measurement of FVC and FEV1. Oxygen saturation (O2 sat)
was measured with a pulse oximeter (Minolta Pulse Ox-7;
Catalyst Research, Div of Mine Safety Appliances Co; Pittsburgh,
Pa) every 30 min starting on arrival and ending 1 h after the last
treatment. Patients coughed and expectorated sputum ad libi-
tum, except for CPT, where they were encouraged to cough in
regular intervals. They were instructed to swallow all saliva before
coughing. The sputum was collected on an hourly basis in
preweighed and labeled sputum cups.
After 1 h of sputum collection (baseline sputum weight),
patients were randomized to one of the five treatment protocols.
For 4 consecutive hours, the patients underwent treatment for 20
min followed by 40 min of sputum collection. Thereafter, sputum
was collected for 1 more hour.
Data Analysis
The wet and dry weights for all sputum collections were
measured. Sputa were dried by heating in a commercial micro-
wave oven until all water had evaporated. Some sputum samples
were considerably contaminated with saliva and the sputum had
to be manually separated with the help of a pair of tweezers
before weighing.
To assess the effect of the treatments on the weight of
expectorated sputum, the sputum weights from hours 2 to 6 were
averaged and expressed as percentage of the baseline sputum
weight.
To assess any change in O2 sat, the mean O2 sat during and
after treatments was expressed as percentage change from base-
line.
To assess the effects of the treatments on PFTs, the percentage
change in FVC and FEV1 after each treatment and between
study entry and exit was calculated.
Statistics
Because the data were not normally distributed and the
treatment effects had different variances, data were analyzed
using nonparametric tests. Friedman analysis of variance was
used to test for differences in mean baseline sputum weights,
for differences in treatment effects among the various treat-
ments, for differences in treatment-related change in PFT
results, and treatment-related change in O2 sat. The Wilcoxon
Matched Pairs Test was used to test for changes in PFT results
before and after treatments, between study entry and exit, and
for change in O2 sat between study entry and exit. The
Mann-Whitney U Test was used to test for differences in
treatment effect between patients who were and were not
receiving rhDNAse. Calculations were made using a personal
computer and software (STATISTICA; StatSoft Inc; Tulsa,
Okla). Significance was accepted when p,0.05. Sample size
estimations for a type I error of 5% and a type II error of 20%
were made using tables provided by Kastenbaum et al.25
Data in tables, text, figures, and legends are presented as
mean6SEM unless otherwise indicated.
CHEST / 113 / 4 / APRIL, 1998 1021
 Results The increase in the weight of expectorated sputum
Study Population ranged between 122626% and 185623% (Fig 1).
No treatment proved to be significantly more effec-
Fifteen patients were enrolled in the study. Due to tive than the others.
transportation problems, one patient requested to Patients using and patients not using rhDNAse
exit after the first treatment. Fourteen patients had similar increases in weight of expectorated spu-
completed the study and were available for evalua- tum for any treatment modality (Table 3).
tion. The characteristics of the study population are
shown in Table 1. One patient had normal PFT PFTs and O2 Sat
results, four were mildly obstructed, five were mod-
erately obstructed, and four were severely ob- FVC, FEV1, and O2 sat showed no significant
structed. Except for three patients, all used bron- change after any of the five treatment modalities
chodilators (either inhaled b2-agonists and/or (Figs 2 and 3) and between study entry and exit.
ipratropium bromide). Eleven regularly inhaled
Complications
rhDNAse.
Three patients developed streaky hemoptysis dur-
Weight of Expectorated Sputum ing the treatments (one patient during treatment
Wet Sputum: The mean baseline sputum weights with SenB, one during HayOp, and one during
for the various treatments ranged between 4.361.2 g MCT1) that resolved spontaneously without inter-
and 7.663.1 g. There was no significant difference rupting treatments.
among them.
Patient Tolerance and Comments
The increase in the weight of expectorated sputum
(average of hours 2 to 6 as percent of baseline) Seven patients stated that the oral airway oscilla-
ranged between 123616% and 168624% for the tors were uncomfortable. Two patients felt that the
five treatment modalities (Fig 1). No treatment treatments with the chest wall oscillators were most
proved to be significantly more effective than the comfortable, two preferred all the mechanical de-
others. vices over CPT, while two patients preferred CPT.
There was no difference between patients who
inhaled rhDNAse (n511) and those who did not
(n53) (Table 2). Discussion
Dry Sputum: The mean baseline sputum weights
for the treatments ranged between 0.1460.04 g and The results of our study show that high-frequency
0.4160.08 g. There was no significant difference oral airway oscillation, high-frequency chest wall
among them. oscillation, and conventional CPT have comparable
augmenting effects on the weight of expectorated
Table 1—Patient Characteristics* sputum in patients with stable CF. By comparing
weight of expectorated sputum during treatment
Patient No./Age, FVC, FEV1, BsI O2
with a preceding baseline period, day-to-day varia-
yr/Sex (F/M) BMI % Pred % Pred sat, %
tion in sputum expectoration was taken into account.
1/25/F 19.5 42 29 96 The reason to analyze wet and dry sputum weights
2/34/M 27 100 83 97
was that some patients had difficulties delivering
3/20/F 17.6 63 47 97
4/14/F 19.6 62 37 96 lower airway secretions without contamination with
5/17/F 19 85 70 96 saliva. Although we were able to manually separate
6/17/F 20.5 90 74 97 lower airway secretions from saliva with a pair of
7/16/M 22 85 67 95 tweezers, contamination with saliva was not elimi-
8/16/M 23.4 96 82 96
nated entirely. Due to its high water content, saliva
9/18/M 25.1 82 72 95
10/29/M 17.4 56 35 95 adds considerable weight to the samples. By evapo-
11/14/M 21.7 59 54 96 rating the water, an important part of this confound-
12/15/M 16.1 64 48 97 ing factor is eliminated. The fact that for almost all
13/27/M 16.7 50 33 95 treatments the relative increase in weight of expec-
14/12/F 18.9 101 89 96
torated sputum was greater for the dried samples is
Mean6SD 20.3 6 3.2 73.9 6 19.5 58.5 6 20.6 96 6 0.8
19.4 6 6.3 in keeping with our assumption. Dry weights might
(6F/8M) therefore better represent lower airway secretions
*F/M5female/male; BMI5body mass index; FVC % pred5percent than wet weights. However, this question cannot be
of predicted FVC; FEV1 % pred5percent of predicted FEV1; answered by this study and further experiments are
BsI5baseline; O2 sat %5percent of arterial O2 sat. needed to clarify the issue.

1022 Clinical Investigations

 Figure 1. Effect of treatments on increase of wet and dry weights of expectorated sputum. The
average weight expectorated during hours 2 to 6 was expressed as percent of baseline (mean6SEM).
There was no significant difference among treatments (n514, p50.15 for wet weight, and n514,
p50.57 for dry weight).

An increased weight of expectorated sputum may
or may not reflect a reduction in the amount of lower
airway secretions, the ultimate goal of the treatment
modalities we tested. We cannot rule out that oscil-
lations and CPT induce secretion of lower airway
mucus, and if so, the increased weight of expecto-
rated sputum reflects the secretory effect of the
treatment. A complicated method such as radioaero-
sol clearance would be needed to test this possibility.
However, the difficulty to obtain informed consent
from parents and guardians (due to prejudice and
fear of harmful effects from radioactivity with radio-
aerosols in adolescents) precluded the use of this
method. We therefore used sputum weight as our
quantitative end point as has been used in several
previous studies involving CPT.2,3,5,6,17

Table 2—Effect of Treatments on Wet Weight of Table 3—Effect of Treatments on Dry Weight of
Expectorated Sputum* Expectorated Sputum*

Treatment rhDNAse Mean6SEM, % p Value Treatment rhDNAse Mean6SEM, % p Value

Airway 1 144.9 6 29.1 0.59 Airway 1 189.7 6 48.9 0.59

8 Hz, 9:1† 2 153.8 6 98.7 8 Hz, 9:1† 2 136.9 6 59.6
Airway 1 129.5 6 20.1 0.31 Airway 1 141.3 6 30.0 0.07
14 Hz, 8:1† 2 97.7 6 17.9 14 Hz, 8:1† 2 50.7 6 12.9
Chest wall 1 137.0 6 44.6 0.48 Chest wall 1 164.9 6 32.6 0.48
3 Hz, 4:1† 2 120.5 6 33.9 3 Hz, 4:1† 2 113.4 6 36.0
Chest wall 1 115.5 6 19.8 0.94 Chest wall 1 126.3 6 28.1 0.82
16 Hz, 1:1† 2 196.2 6 131.5 16 Hz, 1:1† 2 209.1 6 146.5
1.5 Hz, 6:1† 1.5 Hz, 6:1†
CPT 1 186.7 6 27.7 0.10 CPT 1 193.2 6 23.3 0.59
2 99.3 6 9.6 2 155.8 6 72.2
*Comparing the group that inhaled rhDNAse (n511) with the one *Comparing the group that inhaled rhDNAse (n511) with the one
not receiving (n53) this medication did not reveal any significant not receiving (n53) this medication revealed no significant differ-
difference for any treatment. ence for any treatment.
† †
I:E ratio. I:E ratio.

CHEST / 113 / 4 / APRIL, 1998 1023

 Figure 2. Effect of treatments on pulmonary function parameters. Mean changes expressed as percent
of baseline (mean6SEM) are depicted for all treatments. None of the parameters was significantly
altered by the treatments.
The OCI was created based on theoretical consid-
erations and on results of previous experiments
which demonstrated that through air-liquid interac-
tion, mucus is transported within the airways.26-29
Airway wall radial displacement may help disengage
the secretions from the airway wall and thereby
enhance the effect of air-liquid interaction on mucus
movement.28,30 For mucus transport in a cephalad
direction, an expiratory bias flow is mandato-
ry.11,14,15,21 In the OCI (OCI5[f[Hz]3(Fmaxe/Te)/
(Fmaxi/Ti)]2f), frequency, inspiratory and expira-
tory flows, and time of inspiratory and expiratory
airway wall displacement are arranged to obtain a
higher index for better movement of mucus in a
cephalad direction. Thus, the higher the f, the higher
the expiratory flow, the lower the inspiratory flow,
the faster the inward displacement of the airway wall
during expiration, and the slower the outward dis-
placement during inspiration, the higher becomes
the index. Without any bias flow and with equal
times of inspiratory and expiratory airway wall dis-
placement, the OCI equals zero.
In our preliminary experiments, we systematically
tested multiple settings for the chest wall and the
oral airway oscillator to reach the highest OCI.24 This
led to the settings in SenB and HayOp. However, for
MCT1, HaySe, and CPT, we did not calculate the
OCIs. This study, therefore, was not designed to
validate the OCI. The fact that SenB, which resulted
in much higher OCIs than HayOp, tended to per-
1024
form better than HayOp, and both “optimized”
treatments (SenB and HayOp) tended to be superior
than the manufacturer-provided settings (which
were not optimized according to our theoretical
considerations), might be a hint that the OCI is of
some value. However, the differences between all
the treatments were minor and not statistically sig-
nificant. Further experiments are clearly needed to
find out if the OCI is a valid index.
Estimations of required sample sizes revealed that
at least 300 patients are needed to achieve a power of
80% with a type I error of 5% for differences in
means and variances that lie in the range of our
study. Because we did not know the expected effects
of the various treatments on sputum weight, sample
size calculations could not be done in advance. The
high variability between patients and the small dif-
ferences between treatments resulted in the need of
a large sample size for reasonable type I and II
errors. In light of the many possible advantages of
self-treatment, which is feasible with the oscillatory
devices, the small differences between the treatment
modalities might lose their importance, especially if
compliance can be improved.
Comparing expectorated sputum weight in pa-
tients using and patients not using rhDNAse failed to
reveal a significant difference. Almost all patients in
our study were receiving rhDNAse, which compli-
cates statistical comparison. However, our findings
are in keeping with the work of Laube et al,31 which
Clinical Investigations
 Figure 3. Effect of treatments on O2 sat. Mean changes from baseline expressed as percent change
from baseline (mean6SEM) are depicted for all treatments. There were no significant differences
among the treatments.
did not achieve an increase in mucociliary clearance
or improvement of airflow obstruction for patients
inhaling rhDNAse when compared with placebo.
Our results are consistent with findings of previous
experiments, which showed that high-frequency
chest wall oscillation is at least as effective as CPT in
patients with CF who are in stable condition20,32,33 or
suffer from acute exacerbation.17,18,32 To our knowl-
edge, this is the first study that included oral airway
oscillation. The results indicate that the increase in
sputum weight by airway oscillations approximates
the CPT-induced increase.
CPT has been shown to improve or to slow
deterioration of pulmonary function in patients with
CF.9,10,34-37 Short-term improvements in PFT results
are thought to be caused by relief of mucus-related
obstruction.34 The absence of short-term improve-
ment in PFT results in our study can be explained by
the fact that the patients were in clinically stable
condition and did not manifest mucus plugging. Our
finding is also consistent with the report of Wilmott
and coworkers38 who did not find any beneficial
effects of CPT on PFT results in patients with CF
who had an acute exacerbation.
Our patients were in a stable condition and this
may explain the observed lack of detectable treat-
ment-induced changes in O2 sat. Patients with acute
exacerbations may behave differently. McDonnel
and coworkers39 observed acute deteriorations in O2
sat by CPT in their hospitalized patients with acute
exacerbation. Connors and coworkers40 were able to
show that among patients with acute nonsurgical
lung disease, patients with excessive airway secre-
tions maintained their O2 sat, while patients without
hypersecretion experienced oxygen desaturation.
Another possible explanation why O2 sat failed to
change in our patients may have been their normal
baseline values. Small changes in arterial oxygen
tension may have been missed given the sigmoid
shape of the oxygen-hemoglobin dissociation curve.
High-frequency chest wall oscillation is able to
improve oxygenation and ventilation in patients with
normal lungs,41,42 in patients with respiratory fail-
ure,43 and in patients with COPD.44-46 These effects
have been attributed to improved interregional and
intraregional gas mixing.47-52 These beneficial actions
would not have been reflected by our O2 sat mea-
surement which was made after, not during, the
treatment period.
High-frequency oral airway and chest wall oscilla-
tions were both well tolerated. No patient developed
bronchospasm. Three patients with a history of
CHEST / 113 / 4 / APRIL, 1998 1025
hemoptysis developed trace amounts of blood in the
sputum in two or three samples while receiving
treatment (two while receiving oral airway oscillation
and one while receiving chest wall oscillation). All
these episodes resolved spontaneously without inter-
rupting treatment. Arens and coworkers17 made
similar observations. They treated 25 CF patients
with acute exacerbations three times per day over at
least 14 days with high-frequency chest oscillation.
Only two patients developed mild hemoptysis that
stopped after interrupting the treatments for 24 h.
Warwick and Hansen10 applied chest wall oscillation
to 16 CF patients over 7 to 26 months one to four
times per day without observing any adverse effects.
It therefore seems that these new treatment modal-
ities are safe.
Overall, our patients did not show a preference for
any of the treatments. However, they did not have
the option to self-administer treatments at home.
Informal polls have shown that patients like the
independence from caregivers during treatments
that the newer devices offer, and therefore tend to
prefer chest wall oscillation over conventional
CPT.19 Minor uncomfortable side effects like drying
of the mucous membranes during oral airway oscil-
lation are readily relievable by humidification.
Many patients do not like conventional CPT be-
cause it is uncomfortable and time consuming. These
inconveniences inherent in conventional CPT con-
tribute to the low compliance rates that are reported
to be in the range of 26 to 47%.53-57 It is conceivable
that compliance can be improved by the availability
of simple, effective, and easy-to-use devices that
allow independent treatment at home. Devices to
apply oral airway and chest wall oscillation fit these
criteria. Considering their effectiveness and their
potential to reduce health-care costs by permitting
self-administration,58 they appear to represent a
useful alternative to conventional CPT.
ACKNOWLEDGMENT: The authors thank Willy Gregory,
RRT, University of Miami School of Medicine, for his technical
assistance.
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