REVIEW ARTICLE

David S. Warner, M.D., Editor

Home Noninvasive Ventilation
What Does the Anesthesiologist Need to Know?
Karen A. Brown, M.D.,* Gianluca Bertolizio, M.D.,† Marisa Leone, R.R.T.,‡ Steven L. Dain, M.D.§

the safe prescription of NIV therapy. The medical device
design requirements developed by the Organization for International Standardization provide a framework to rationalize the safe prescription of NIV for hospitalized patients supported at home with NIV systems. This review article
provides an overview of the indications for home NIV therapy, an overview of the medical devices currently available to
deliver it, and a specific discussion of the management conundrums confronting anesthesiologists.

ABSTRACT
Treatment of chronic respiratory failure with noninvasive
ventilation (NIV) is standard pediatric practice, and NIV
systems are commonly used in the home setting. Although
practice guidelines on the perioperative management of children supported with home NIV systems have yet to be published, increasingly these patients are referred for consultation regarding perioperative management. Just as knowledge
of pharmacology underlies the safe prescription of medication, so too knowledge of biomedical design is necessary for

N

ONINVASIVE ventilation (NIV) refers to a technique of augmenting alveolar ventilation without the
requirement for an invasive artificial airway. The use of NIV
in the home was introduced in the 1980s for the long-term
treatment of sleep apnea, and has more recently been used for
the management of chronic hypercapnic respiratory failure.
Management of acute respiratory failure may also include
NIV, both to avoid invasive ventilation and to facilitate
weaning from mechanical ventilation. Interested readers are
referred to a recent review in Lancet.1 This review focuses on
the use of NIV in the home for the management of chronic
stable respiratory failure and/or obstructive sleep apnea.
Children with Duchenne muscular dystrophy were
among the first patients to be managed with domiciliary NIV
therapy. Children currently represent 10% of patients managed in home ventilation programs.2 Children on home NIV
therapy are now presenting to anesthesiologists for diagnostic
and surgical procedures. There are substantial questions concerning the optimal management of these children: Should
they be permitted the use of their own domiciliary NIV
medical devices? Are they eligible for ambulatory surgical
programs? With respect to their own NIV medical devices,
the ECRI Institute (formerly Emergency Care Research Institute) has cautioned hospitals against the use of patientsupplied medical equipment.3,4 The answers to the above
require a working understanding of the indications for home
NIV therapy, the medical devices used to deliver it, and the
impact of sedative and analgesic medications on NIV therapy. This review provides an overview of the indications for
NIV therapy, an overview of the medical devices available to

* Professor, Division of Pediatric Anesthesia, McGill University
Health Center Research Institute, Montreal Children’s Hospital,
Montreal, Quebec, Canada, and Vice-Chair, Canadian Advisory
Committee for the International Organization for Standardization,
Technical Committee 121, Subcommittee 3 Breathing Machines.
† Clinical Fellow, Shriners Hospital for Children Pediatric Anesthesia
Fellowship, McGill University, Montreal, Quebec, Canada. ‡ Assistant Chief Respiratory Therapist, Department of Pediatric Respiratory Therapy, Montreal Children’s Hospital of the McGill University
Health Center, Montreal, Quebec, Canada. § Associate Professor,
Department of Anesthesia and Perioperative Medicine, Schulich
Medicine and Dentistry, University of Western Ontario, London,
Ontario, Canada, and Chair, Canadian Advisory Committee for the
International Organization for Standardization, Technical Committee 121, Subcommittee 3 Breathing Machines.
Received from the Division of Pediatric Anesthesia, McGill University Health Center Research Institute, Montreal Children’s Hospital, Montreal, Quebec, Canada. Submitted for publication November 23, 2011. Accepted for publication May 12, 2012. Dr. Brown is
supported by the Queen Elizabeth Hospital of Montreal Foundation
Chair in Pediatric Anesthesia, McGill University, Montreal, Quebec,
Canada, and Dr. Bertolizio was supported by the Shriners Hospital
for Children Pediatric Anesthesia Fellowship, Montreal, Quebec,
Canada. Figures 1, 4, 6, and 9 were created by Annemarie B.
Johnson, C.M.I., Medical Illustrator, Wake Forest University School
of Medicine Creative Communications, Wake Forest University
Medical Center, Winston-Salem, North Carolina.
Address correspondence to Dr. Brown: Division of Pediatric
Anesthesia, McGill University Health Center/Montreal Children’s
Hospital, 2300 Tupper Street, Rm. C-1118, Montreal, Quebec H3H
1P3 Canada. roula.cacolyris@muhc.mcgill.ca. This article may be
accessed for personal use at no charge through the Journal Web site,
www.anesthesiology.org.
Copyright © 2012, the American Society of Anesthesiologists, Inc. Lippincott
Williams & Wilkins. Anesthesiology 2012; 117:657– 68

Anesthesiology, V 117 • No 3

657

September 2012

children with deteriorating respiratory status were supported with a succession of increasingly complex medical devices.do?uri⫽CELEX: 31993L0042:EN:HTML. First.e. bilevel airway pressure therapy aims to splint the pharyngeal airway and preserve lung volume. An Overview of the Indications for Domiciliary NIV Medical Indications for Home CPAP Therapy.18 The use of NIPPV therapy during sleep enhances gas exchange and decreases the work of breathing.11 In patients with coexistent pulmonary disease and OSA. Accessed April 30. . Therefore. noninvasive ventilation employs a nonhermetic technique. children are followed in outpatient clinics. CPAP therapy may improve cardiac function. Preoperative consultation with the sleep physician or respirologist is important.13 Failure of home NIV therapy occurs more often in these children. morbid obesity. whereas invasive ventilation bypasses the upper airway with a endotracheal tube.. NIPPV is also referred to by the acronym NPPV (noninvasive positive pressure ventilation) and BiPAP (bilevel positive airway pressure). Second.e.6 CPAP therapy is currently widely prescribed for the management of OSA in adults and in children with OSA refractory to adenotonsillectomy. Class I medical devices are not intended for use in sustaining or sup- 储 http://eur-lex. preoperative consultation with these physicians is important.9 It also increases lung volume (i. both of which deliver a therapeutic positive airway pressure. Medical Indications for Home NIPPV Therapy. because the use of NIV therapy in the pediatric patient exposes the limitations of NIV systems. However. Initiation of CPAP therapy usually involves a CPAP titration study in a sleep laboratory. 2012. the noninvasive ventilation system incorporates the upper airway into the breathing pathway.europa. In adult patients. and they have difficulty handling secretions. because their vital capacity is usually less than 25% predicted. In chronic respiratory failure associated with neuromuscular disease and An Overview of the Medical Devices Available to Deliver Domiciliary NIV Therapy The acronym NIV is frequently applied to both the therapy and the device that delivers the therapy. reduce the load on respiratory muscles. Once discharged home on CPAP devices.21 As pulmonary function declines. respiratory support during wakefulness may also be indicated. In patients with coexistent heart failure and OSA.Noninvasive Ventilation Devices deliver NIV therapy. offset auto-positive end-expiratory pressure. The discussion focuses on children. CPAP therapy may also improve gas exchange. Children who require both nocturnal and diurnal NIPPV are at very high risk for respiratory complications. NIPPV therapy further augments airway pressure by increasing inspiratory airflow in order to provide an inspiratory assist to the muscles of respiration. Anesthesiology 2012.eu/LexUriServ/LexUriServ. respiratory muscle weakness may lead to hypoventilation during both sleep and wakefulness. culminating in tracheostomy and invasive ventilation. CPAP therapy may also improve lung function. 117:657– 68 658 Brown et al. i. Parents and children currently may prefer to continue with NIPPV therapy. The technique of noninvasive ventilation has two unique features that distinguish it from invasive ventilation with a endotracheal tube. and a specific discussion of management conundrums facing anesthesiologists. because they form the liaison with the home ventilation program. in order to avoid tracheostomy and thereby preserve phonation and swallowing functions important to their quality of life.8 During CPAP therapy. PA). In 1981. the positive airway pressure acts as a pneumatic splint for the pharyngeal airway. including scheduled overnight polysomnography studies. NIPPV therapy in adult patients has been shown to improve tidal volume and minute ventilation by 33% and 17%. functional residual capacity).12 Prescription of home CPAP therapy in children is reserved for those with OSA refractory to adenotonsillectomy.18 During inspiration.13. Like CPAP therapy. Medical supervision is provided by sleep physicians and respirologists who provide periodic review. Colin Sullivan introduced CPAP therapy as a modality to reverse the symptoms of obstructive sleep apnea (OSA).20 Both exercise tolerance and quality of life improve..5 varying in biomedical design complexity from simple sleep apnea equipment to sophisticated home and critical care ventilators with NIV capabilities.7. CPAP levels of 5 and 10 cm H2O may increase tidal volume by 80 ml and 150 ml. and their management requires periodic review with overnight polysomnography. Regulatory bodies classify medical devices by risk储.12–19 NIPPV therapy aims to deliver a therapeutic pressure during inspiration – the inspiratory positive airway pressure (IPAP) – and hold a positive pressure on exhalation – the expiratory positive airway pressure (EPAP). and the mask interface is deliberately designed to leak. daytime hypercapnia with an increased serum bicarbonate level.2 Children requiring domiciliary NIPPV therapy are supported and managed in comprehensive home ventilation programs. respectively. these pediatric concerns may also be relevant to small adults and patients with poor respiratory muscle strength and reduced respiratory neural drive. and decrease the work of breathing. In the past. and BiPAP® is also the name of a NIV medical device manufactured by Philips Respironics (Murrysville. Indeed. Management of chronic hypercapnic respiratory failure with domiciliary NIPPV in children with neuromuscular and chest wall disease is now standard practice. respectively. and a low oxygen saturation on room air during wakefulness.10 Both actions act to decrease the collapsibility of the upper airway and thereby mitigate obstruction of the pharyngeal airway. There are presently more than two dozen brands of medical devices to deliver NIV therapy.5 NIV modalities include continuous positive airway pressure (CPAP) and noninvasive positive airway pressure ventilation (NIPPV). Hallmarks of hypoventilation during wakefulness are a chronic compensated respiratory acidosis.

These design requirements provide a framework to compare the available medical devices with those that deliver home NIV therapy (table 1). . and are subject to postmarket surveillance. hearing aids and wheelchairs. are designed to perform without causing injury. alarms are mandatory More than $15.000 $6. develop international standards that provide the requirements for basic safety and performance of medical equipment. Medical devices to deliver NIV therapy include both Class I and Class II medical devices. are required to meet mandatory performance standards. Examples of Class I medical devices are stethoscopes. accuracy ⫾ 20% actual value Mandatory Mandatory: Expiratory tidal volume or expiratory minute ventilation or expiratory end-tidal carbon dioxide ⫾20% actual value Mandatory Mandatory Mandatory Mandatory 40 cm H2O (40 hPa) 40 cm H2O (40 hPa) 60 cm H2O (60 hPa) 60 cm H2O (60 hPa) Mandatory Mandatory Mandatory Mandatory Not required Not required Not required Not required Mandatory Not required Mandatory Mandatory Not required Not required Not required Mandatory Not required Not required Not required Not required Not required Not required Mandatory If a capnometer present.000–$5.000 $2.EDUCATION Table 1. ISO 17510 Part 1. Design Features of Class I and Class II Medical Devices Available for Home Noninvasive Ventilation Sleep Apnea Breathing Therapy Equipment: Continuous Positive Airway Pressure Device Sleep Apnea Breathing Therapy Equipment: BiLevel Positive Airway Pressure Device Home-care Ventilatory Support Devices Home-care Ventilators for Ventilator-dependant Patients ISO standard Medical devices classification Design Intended to deliver ISO 17510–1: 2007 Class I ISO 17510–1: 2007 Class I ISO 10651–6: 2004 Class II ISO 10651–2: 2004 Class II Positive airway pressure Positive airway pressures Positive airway pressure Intended for use during spontaneous breathing Intended to be life supporting Intended for use during apnea Intended for use with a nonhermetic mask design Intended for use with tracheal tube Monitors Airway pressure Ventilation Yes Yes Yes Positive airway pressure and ventilation Yes No No No Yes No No No Yes Yes Yes NIV mode option NIV mode option No No Invasive ventilation mode option Invasive ventilation mode option Mandatory Optional Mandatory Optional Mandatory Optional Specified accuracy for the expiratory volume monitor Protection Devices Means to allow spontaneous breathing during device failure Maximum NIV system pressure Means to prevent rebreathing Alarm conditions High-inspiratory pressure Continuing positive pressure High and low expiratory tidal volume and minute ventilation Hypoventilation High and low end-tidal CO2 Purchase price (USD) No No If volume monitor provided.000 ISO ⫽ Organization for International Standardization. USD ⫽ United States dollars. (table 1) Class I medical devices are less expensive than Class II ventilators.000 Less than $1. porting life and do not present a risk for injury.22 Class II ventilators with NIV capabilities comply with ISO 10651– 623 or ISO 10651–2. Class II medical devices are intended to support life. 117:657– 68 The Organization for International Standards (ISO) and the International Electrotechnical Commission. both worldwide networks of national standards institutes. Examples of Class II medical devices are infusion pumps and ventilators. Class I NIV devices comply with the standard.24 For the 659 Brown et al. a reality that renders them cost-effective for home use. Anesthesiology 2012.

NIV ⫽ noninvasive ventilation. a design feature that facilitates the delivery of a constant positive airway pressure throughout the phases of the respiration. Essential components of noninvasive ventilation (NIV) systems using double (AA. the expiratory flow can only be measured directly if the spirometer is interposed between the expiratory valve and the patient (fig. or air compressors. Jullien V.. expiratory airflow cannot be measured directly. it is supplied by a servo-controlled air compressor. Reproduced with permission from Rabec et al. In addition. The NIV mask complies with ISO 17510 –2. the imperfect seal of the mask to the face is an additional source of leakage: the unintentional leak. AB) or exhaust port (BC. Rev Mal Respi 2004.5 In double-limb circuits. Expiratory airflow is only measurable when the flow meter is located between the patient and the expiratory valve (A2). the breathing circuit. Single-limb circuits are the usual circuit used to deliver home NIV therapy. 21(3):556 – 66. vices and Class II ventilators with NIV capabilities. which also contains a pressure regulation valve.and single-limb circuits – are available for use in NIV systems. 2A). These design features include a high rate of gas flow and/or an alternate inspiratory pathway. NIV systems complying with ISO 17510 Part 1 will be referred to as NIV devices. When applied to the face. Delivery of NIV therapy relies on a nonhermetic technique and requires a high-resistance exhaust port/expiratory valve located on the mask or mask connection. compressed gas. Single-limb circuits lack an expiratory valve (figs. and the NIV mask. AB) and single (BD. as illustrated in figure 2. purpose of this discussion. Whereas the driving pressure for the flow generator in critical care ventilators is supplied from either pipelines. 2BC. the level of inspiratory gas flow delivered through the breathing tube ranges from 20 to 60 l/min. 1) All NIV systems are designed to deliver a therapeutic airway pressure and achieve a positive airway pressure by directing airflow into a mask equipped with a high-resistance exhaust port or expiratory valve. The same ventilator may be equipped with both noninvasive and invasive ventilation modalities. (fig.5 modified from Perrin C. The exhaust port may be located in the noninvasive ventilation mask or mask connection. In double-limb circuits. In the three other configurations. In single-limb circuits. 2A2). The exhaust port discharges a continuous intentional leak during normal operating conditions. BD). . Components of a single-limb circuit noninvasive ventilation system. BD). In normal operation. 1. In all systems. with shifts in the mask position and with changes in the 660 Brown et al. Two different circuits – double. the inspiratory and expiratory breathing pathway share a common conduit. NIV systems lack a reservoir bag. Lemoigne F: Aspects pratiques et techniques de la ventilation non invasive.25 The NIV mask is used interchangeably with Class I NIV deAnesthesiology 2012. Pressure and flow sensors are housed in the flow generator. 2. However. the expiratory flow cannot be directly measured.Noninvasive Ventilation Devices Fig. BC) circuits. this results in an intentional leak and pressurizes the NIV system. and in single-limb circuits. in home NIV systems. the absence of a reservoir bag requires a design that ensures an adequate peak inspiratory flow rate. the flow generator directs a high rate of gas flow through the inspiratory pathway to a NIV mask equipped with an expiratory valve interposed in the circuit (AA. NIV systems complying with ISO 10651– 6 or ISO 10651–2 will be referred to as ventilators with NIV capabilities. The essential components of NIV systems are the flow generator. 117:657– 68 Fig. The magnitude of the unintentional leak varies with the phase of respiration. NIV ⫽ noninvasive ventilation. there are separate inspiratory and expiratory breathing pathways and an expiratory valve (fig.

in excess of 20 l/min. Asynchrony between the child and NIV system during the inspiratory trigger is common especially during sleep. The Inspiratory Trigger between EPAP and IPAP The trigger for IPAP is initiated by the patient’s inspiratory effort and is detected by a change in airway pressure or gas flow within the NIV system. If the expiratory trigger failed and the high inspiratory gas flow continued during expiration.27 NIPPV Systems. home NIV devices are intended for dedicated use in single patient and are not designed to function with in-line filters. Second. effectively instituting a controlled mode of ventilator support. Modern NIV devices are equipped with microprocessors and sophisticated proprietary algorithms that adjust the rate of gas flow to compensate for the variable unintentional leak. allowing the mask to be adjusted to comfort. For these children.8 In addition. CPAP Devices. a maximum inspiratory time of 0. the NIV system–lung assembly does not behave as a single compartment model. all NIV systems are equipped with a pressure regulation valve in the flow generator and design features to limit the maximum pressure to 40 cm H2O in Class 1 NIV devices and to 60 cm H2O in Class II ventilators with NIV capabilities (table 1).8 NIV devices. because the upper airway presents a variable resistance. And third. particularly those with poor respiratory muscle strength.18 However. or anesthesia mask. Home ventilators for invasive ventilation are indicated in tracheostomized patients. Too tight a mask. The Expiratory Trigger between IPAP and EPAP The trigger for expiration may be either a function of time or a threshold decline in inspiratory flow.22. First.5 Volume-targeted Devices Volume-targeted NIPPV devices deliver a set flow to the airway for a defined time interval or until a preset volume is obtained.1 Although the patient connection port may be a 15 mm/22 mm connector.5 s is often used.5 The two basic NIV modalities are pressure-targeted NIPPV and volume-targeted NIPPV. ill-fitted mask risks skin injury and ulceration. laryngeal mask. respectively.26 and trigger the transitions between IPAP and EPAP. Sophisticated proprietary algorithms have been developed to detect phasic changes in gas flow. until the predefined positive airway pressure target is attained. may adversely affect the growth and development of facial bones. The presence of leaks at the mask interface requires a design feature capable of delivering very large gas flows during the inspiratory phase of the respiratory cycle. The NIV mask design is deliberately nonhermetic. risking barotrauma and injury. Increasing the airway pressure may not increase the effective ventilation to the patient. a tight. Although NIV systems will fit a 15 mm/22 mm connector.8 These gas flow rates may exceed 150 l/min. allowing the tongue to obstruct the upper airway. gas waveforms. The mask must be soft and secure and yet allow for sweating.3– 0. 117:657– 68 661 Brown et al. The usual levels of IPAP and EPAP range from 10 to 16 cm H2O and from 4 to 5 cm H2O.25 NIV systems are not designed for use with a endotracheal tube. NIPPV devices have less pressure-generating capacity than ventilators. tracheostomy tube.26.28 because their low rates of inspiratory flow may be insufficient to initiate the inspiratory trigger. worn over many years. The Interface and the NIV Mask NIV therapy is delivered with a nasal or full-face mask.26 The minimum performance for the delivery of positive airway pressure is ⫾ 1. all NIV devices are equipped with a pressure sensor located in the flow generator to detect high airway pressure.8 In children. they are not intended for use with tracheal tubes. Pressure-targeted NIPPV Systems Most bilevel pressure NIV systems achieve the IPAP level by increasing the rate of gas flow during inspiration. The selected backup rate is often set at a rate higher than the child’s spontaneous rate during sleep.5 Most modern NIV systems achieve the transitions between IPAP and EPAP with flow-based triggers.8 This is one of the reasons NIV devices are not intended for use in patients weighing less than 30 kg. CPAP devices are designed to deliver a continuous distending pressure throughout the patient’s respiratory cycle. the patient could become hyperinflated. however. This requires design features that sense the phase of respiration8. and IPAP is titrated to attenuate hypercarbia during sleep. are not intended for use in apneic patients (table 1). It is beyond the scope of this review to discuss all NIV modalities. and therefore some homecare NIV protocols require a backup ventilation rate.23 NIV systems have three additional design features.7 The magnitude of inspiratory assist depends on the difference between IPAP and EPAP. NIPPV devices are designed to deliver a cyclical application of two levels of positive pressure: IPAP and EPAP. and flow reversal(s). The majority of home NIV systems use pressure-targeted modalities.5 cm H2O of the set pressure. The sensitivity of the trigger function represents an important limit to the use of NIPPV in small children.22. The EPAP is titrated to eliminate obstructive airway events.18. The leak around an invasive uncuffed tracheostomy tube is insufficient to adequately discharge the high rate of inspiratory gas flow.EDUCATION compliance and resistance of the upper airway and respiratory system. . Velcro straps applied too tightly to a full-face mask may displace the mandible backward. Anesthesiology 2012. ventilators with NIV capabilities offer a better option. without injury. and readers are directed to a comprehensive review in Thorax.

occurred frequently during large unintentional leaks. Modern NIV systems offer a “volume guarantee” mode that will deliver a minimum level of ventilation when such perturbations occur. For children. The tidal volume decreased transiently during the onset and increased transiently during the offset.8.5 Dual-limb NIV systems mitigate the degree of rebreathing by using an expiratory valve and separating the inspiratory and expiratory pathways. VT ⫽ tidal volume. During normal operation. Washout of carbon dioxide is more efficient if the exhaust port is located within the mask. and the NIV system may not cycle to EPAP.18 allowing the high rate of gas flow to continue even if the patient ceases to inhale. The response to a perturbation was to increase IPAP (fig. when the unintentional leak increased. . NIV ⫽ noninvasive ventilation. or increased unintentional leak. The efficacy of the “volume guarantee” mode was recently tested in six NIV systems. This high gas flow rate will impede exhalation. a large unintentional leak may preclude attainment of the preset IPAP. mouth breathing increases the gas leakage. However. 3).4. chin straps). or the delivery of a Anesthesiology 2012. the magnitude of the inspiratory assist decreases during perturbations such as increased upper airway resistance. the inspiratory and expiratory breathing pathway share a 662 Brown et al. 117:657– 68 Rebreathing Potential in NIV Devices Although the ECRI Institute considers the patient-supplied NIV mask less hazardous than the NIV device.e. breath cycle without the patient triggering a breath. Representative tracing showing the response to a noninvasive ventilation system with a “minimum guarantee” mode to a perturbation..29 Perturbations sufficient to decrease tidal volume (VT) were determined. only one NIV system achieved it. Large unintentional leaks at the mask interface are particularly common in children. five of six NIV systems achieved the guaranteed minimum VT.29 and reprinted with permission. and parents may devise ways and means to ensure the mouth remains closed during sleep (i. The ventilators were set in the “volume guarantee” mode to deliver a minimum VT.5 In a single-limb NIV system. it is the design of the NIV mask that influences the risk of rebreathing. IPAP ⫽ inspiratory positive airway pressure. decreased lung compliance. increasing the work of breathing and risking barotraumas.Noninvasive Ventilation Devices Fig. The onset and offset response times ranged from 1 to 51 breaths. In addition. With perturbations in airway resistance or lung compliance. gastric insufflation. The specific responses to three types of perturbations are shown in the accompanying table. nasal masks are preferred. 3. In pressure-targeted NIV systems. The inspiratory positive airway pressure increased in order to achieve the minimum guaranteed tidal volume. Auto-triggering. and aspiration of stomach contents. Adapted from Fauroux et al. in part to minimize the apparatus dead space and facilitate the trigger functions of the NIV systems.

Rebreathing potential in noninvasive ventilation systems. 5.1. to pass 15 min off NIV without respiratory decompensation. coincident with a fall in inspired oxygen (fig. the minute ventilation.30 In the event of a power failure. battery life is difficult to predict and often brief. an electrical power-off scenario results in rebreathing of exhaled gas. 4). which contains an admixture of fresh and exhaled gas.25 A minimum mandatory EPAP level of 3 or 4 cm H2O (gas flow around 20 l/min) is needed to ensure adequate washout of exhaled carbon dioxide. Although a battery reserve should protect from electrical power failure.22. the rebreathing of exhaled gases will allow a hypoxic admixture to accumulate in the breathing tube (fig. unable to maintain the patency of the upper airway. the short-term exposure limit for inhaled carbon dioxide is 3% (about 22 mmHg). These # http://hc-sc.gc. NIV ⫽ noninvasive ventilation. During normal use. 5). During normal use. 2012. the time-weighted average for inspired carbon dioxide is 1%. 5).30 tion. or have an unstable respiratory status. Anesthesiology 2012. it is expected that the sleeping patient will rouse and remove the NIV mask. the rate of gas flow rate. Class I medical devices may not be equipped with a battery backup. The safe use of NIV to support ventilation following surgery requires selection of both appropriate patients and NIV systems. Several factors influence the inspired oxygen concentra- Can Children Supported with Home NIV Systems Be Managed in Ambulatory Surgical Programs? Class I NIV devices and some Class II ventilators with NIV capabilities are not intended to support life (table 1). The risk of rebreathing is maximal when inspiratory gas flow ceases.31 However. a maximum inspired oxygen concentration of 67% was reported. the design of NIV equipment incorporates a means to allow spontaneous breathing in the event of a device failure. common conduit (fig. supplemental oxygen may be intentionally delivered into the breathing tube or the mask interface. eligibility criteria for NIV support are the ability to call for help. In the event of a power failure.32 Health Canada advises that patients who have a limited ability to adjust or remove the NIV mask should be attended at all times.ca/dhp-mps/medeff/advisories-avis/prof/_2012/ index-eng. As the exhaust port purposely offers a high resistance. This may be accomplished by including an antiasphyxiation valve in the NIV mask. the flow generator directs air into the breathing tube. In the conventional continuous positive airway pressure system (A). Perioperative Management Conundrums in Patients Supported with Domiciliary NIV Patient Selection.33 Inspired Oxygen Concentration During power failure. 117:657– 68 663 Brown et al. In hospitalized patients.php. and the location at which oxygen is delivered into the NIV system. elimination of exhaled carbon dioxide depends on a high rate of gas flow. including the NIV modality. with cessation of gas flow. a limit that assumes that the physiologic arousal response will be sufficient to rouse the patient.30 The risk of rebreathing decreases with increasing airway pressure (higher gas flows). and to maintain oxygen saturation with modest inspired oxygen concentrations. A high rate of gas flow is required to prevent rebreathing during normal use. 4. Therefore. The admixture of fresh and exhaled gas is designed to egress the system via the exhaust port (intentional leak) and noninvasive ventilation mask interface (unintentional leak). the inspiratory oxygen concentration achieved in patients on NIV devices is often less than 50%. A nasal NIV mask should have less risk of asphyxiation because the child can initiate mouth breathing. The NIV systems are designed such that during normal use. the inspired carbon dioxide level will rise precipitously. .# NIV therapy is contraindicated if children are apneic.25 Fig. the expiratory pathway may include the low-resistance breathing tube. and a recognition that the clinical scenario in the hospital differs from that in the home environment. have a reduced level of consciousness. Accessed April 30. a limit which harmonizes with that allowed in occupational health exposure. There is a rapid rise in inspired carbon dioxide and fall in inspired oxygen concentration. Design features that include nonrebreathing valves (B) mitigate the risk for rebreathing. Reproduced with permission from Farre´ et al. mouth breathing may not be possible if chin straps are used.EDUCATION Fig. unable to protect their own airway. However. Gas pathway in noninvasive ventilation system using a single-limb circuit. In healthy volunteers on NIV therapy. In NIV systems. During normal use.

the settings for the NIV system may require adjustment. Discharge criteria for patients supported with home continuous positive airway pressure devices. the availability of expert and adequately trained staff throughout a 24-h period. the CPAP device was misassembled. and the majority of modern NIV systems log parameters of airway pressure for periodic review. Sedative and analgesic medication may blunt arousal and reflex defenses. and for adolescents the maximum is 30 cm H2O. there were no patient-triggered breaths. 7B). the set EPAP and IPAP levels of 4 and 15 cm H2O.24 Home ventilation programs define ineffective ventilation by the failure to attain the set airway pressures. 7 and 8). NIV systems rely on the patient’s reflex and arousal mechanisms to monitor the function of the NIV system. nasal congestion. Monitoring and Alarms: Do NIV Systems Monitor Ventilation? All NIV systems are required to measure airway pressure. However. A feature that distinguishes the Class II NIV systems from Class I NIV devices is the requirement. The recorded tidal volume has decreased to 202 ml. These children are poor candidates for ambulatory programs. Surgeries associated with upper airway edema. and surgical packings may obstruct the upper airway. are now inadequate.32 In addition. Class I medical devices are not designed to monitor patients. An adolescent on continuous NIPPV was found unresponsive on the floor. and supplemental oxygen may be required. 6). 6. an excessive Can NIV Be Safely Administered on Hospital Wards? Expertise of Healthcare Providers. were achieved throughout 13 h of use. bleeding. IPAP levels of 10 –16 cm H2O usually provide sufficient support. their use on hospital wards might seem reasonable.34 Higher levels of IPAP may increase the gas leak. having removed the NIPPV system without notifying his nurse. adequate monitoring. the set EPAP and IPAP levels were identical and achieved throughout 18 h of use. Class II ventilators for ventilator-dependant patients are intended to deliver both positive airway pressure and ventilation and are therefore designed appropriately. and immediate access to invasive ventilation in the event of respiratory deterioration.13 Which Surgical Procedures? As NIV systems include the upper airway in the breathing pathway. Fig.8 l/min. the settings for NIV systems that are adequate in the home environment may not be therapeutic in the postoperative period. Children with continuous home NIPPV therapy have a limited respiratory reserve and are at extreme risk for respiratory complications following anesthesia and surgery.Noninvasive Ventilation Devices intravenous sedation. and ventilation was supported entirely with the NIV system. compromise of nasopharyngeal airway patency may limit the efficacy of NIV therapy. which were therapeutic in the home environment. The estimated tidal volume was 277 ml and the estimated minute ventilation was 6. Because the safe use of NIV systems is predicated on an intact physiologic defense system. to monitor the ventilation of the patient (table 1). and patient well-being is the prime indicator that an NIV device is functioning. Figure 7A is a representative baseline trace of internally logged data from a home NIV system. and she was treated with Anesthesiology 2012. the set EPAP and IPAP levels were unchanged and achieved throughout the 22 h of use. In one case.35 Another patient died because of NIV system failure. The challenges of delivering NIPPV therapy on hospital wards are illustrated by two published scenarios in patients with advanced cystic fibrosis.3 Health Canada advises that medical staff caring for patients supported by NIV systems should be knowledgeable of the capacities and limitations of NIV systems.17 Because NIV devices are used in a home environment. mishaps during NIV therapy have been reported in hospitalized patients. children on domiciliary NIV systems should not be discharged home until these protective and defense mechanisms have returned13 (fig. . During the following night (fig. 8). Pulmonary function may be affected in the postoperative period. However. Children become uncomfortable if IPAP settings exceed 20 cm H2O. at a backup rate of 25 breaths/ min.1. The respiratory status further deteriorated. Trigger asynchrony was suspected.# The safe use of NIV therapy on the wards requires the selection of patients with stable respiratory failure.18 The maximum IPAP for preadolescent children is 20 cm H2O. and the straps securing the NIV mask may require adjustment. in the former. requiring invasive ventilation. likely reflecting a combination of wakefulness and pain. In addition. a data log is not synonymous with a monitor. respectively. but the recorded tidal volume has now decreased to 98 ml. A young adult with chronic respiratory failure developed agitation because of respiratory acidosis. patient-triggered breaths are now present throughout the record. However. The levels of positive airway pressure. During the majority of the record. 117:657– 68 664 Brown et al. Following surgery (fig. and affect the efficacy of NIV therapy. as illustrated in figures from three consecutive nocturnal NIV recordings (figs. and a third death was linked to NIV system-related infection.

NIPPV ⫽ noninvasive positive pressure ventilation.37 In the home environment. changes in the ventilatory status may not be obvious. unintentional leak.33. as Health Canada cautions that rates for spontaneously reported adverse incidents (with NIV systems) are presumed to underestimate the risk. type of circuit. the index of ventilator error exceeded 20%.EDUCATION Fig. especially at high IPAP pressures. whereas the use of patient-supplied NIV masks is condoned.36 Capnography is not used in the home environment. home NIV systems underperform when subjected to high-level re- If Patients on Domiciliary NIV Are Not Being Monitored at Home.# Arterial or capillary blood gases may also be indicated. the accuracy and clinical relevance of the reported physiologic parameters lack validation. trigger sensitivities. EPAP ⫽ expiratory positive airway pressure. the ECRI Institute cautions hospitals against the use of patient-supplied NIV systems. 79% strongly agreed that patients should be restarted on their home NIV therapy as soon as feasible after surgery. In addition. the efficacy of the ventilatory support differed. the set levels of inspiratory positive airway pressure and expiratory positive airway pressure were identical. However. Recent bench studies suggest that VT is underestimated.# A multicenter evaluation of 22 conventional NIV systems reported significant differences between the set parameters and the actual values. 7. Representative figures illustrating the limitations of a noninvasive positive pressure ventilation system in the hospital environment.4 Most countries lack a centralized database for reporting problems with home NIV systems. However. and position of the exhaust port – all of which may affect the quality of ventilatory support.42 and this request may seem reasonable. because the efficacy of the NIV therapy is assessed by patient well-being and periodic review of the internally logged data. ment of carbon dioxide may be more useful in the hospital environment. and the high rate of gas flow. its accuracy in NIV systems may be influenced by dead space. Health Canada advises that hospitalized patients supported with NIV systems must be monitored with oxygen saturation and vital signs. there is no need for bedside reporting of data. Although capnography is available in hospitals. 117:657– 68 665 Brown et al. and frequent desaturation indices. IPAP ⫽ inspiratory positive airway pressure. Some manufacturers have developed sophisticated proprietary algorithms that assess gas flows and estimate the unintentional leaks of the NIV system.2 The lack of reporting is not evidence of safety.39 – 41 In the home environment. In addition. In both the home (A) and hospital (B) use scenarios. . VT.38 Parents and children often request the use their own NIV system while in the hospital. there are proprietary algorithms that estimate the delivered minute ventilation and VT of the patient.8. but currently this feature is not readily available at the bedside. citing differences among NIV systems in leakage. In 17% of patients.3. the NIV systems are reported to be robust and reliable. Transcutaneus measureAnesthesiology 2012. However.36 Should Children Be Permitted the Use of Their Own Domiciliary NIV Systems? Of the task force’s consultants charged with developing guidelines for the perioperative management of patients with OSA. In hospitalized patients it may prove useful to review this internally logged data. Do They Need to Be Monitored While in the Hospital? Unless the ventilation is being monitored at the bedside.

may provide more reliable respiratory support. the level of ventilatory support is much lower. Disabling alarms on ventilators with NIV capabilities negates the safety design features that distinguish Class II from Class I medical devices. all children requiring NIV therapy in the postoperative period are initially admitted to the intensive care unit following anesthesia. to enunciate alarm conditions intended to summon help (table 1). depress respiratory drive. Our recommendations are listed in table 2. low VT) enunciate so frequently they constitute a nuisance and disrupt sleep. Summary Treatment of refractory obstructive sleep apnea and chronic respiratory failure with home NIV is now standard pediatric practice.33. The optimal transition from sedation and/or general anesthesia to their home NIV system is an area of study. however.43 Another major issue with patient-supplied NIV systems is that the alarms have frequently been disabled. 9).43 A feature that distinguishes the Class II NIV systems from Class I NIV devices is the requirement. and practice guidelines for the safe management of patients supported with home NIV systems have yet to be developed. ventilators with NIPPV capabilities. The set levels of inspiratory positive airway pressure and expiratory positive airway pressure remain unchanged from those in figs. their perioperative management. Anesthetic and analgesic medications induce apnea. when the patient’s clinical state may change rapidly. . IPAP ⫽ inspiratory positive airway pressure. decrease compliance of the respira- Recommendations Anesthesiologists increasingly encounter children who are supported on home NIV therapy and are asked for advice on Anesthesiology 2012. and this requirement has not proven problematic. 7A and 7B. As the intensive care unit is the only location in our hospital with continuously available expertise in NIV systems. 117:657– 68 666 Brown et al. quirements similar to those which may occur during the postoperative period. 7. Representative figure in a postoperative scenario showing the limitation of the same noninvasive positive pressure ventilation system illustrated in Fig. NIPPV ⫽ noninvasive positive pressure ventilation.Noninvasive Ventilation Devices Fig. because most (i.. In the postoperative period. At some point before discharge. transition to a domiciliary NIV system and liaison with the home ventilation program is required (fig. Our caseload of the children on home NIV therapy is small. Recovery of both defensive and protective reflexes and transition to the home NIV system should occur before discharge from hospital. EPAP ⫽ expiratory positive airway pressure. 8. in the former. which are designed for ventilator-dependant patients.e.

EDUCATION References 1. Using patient-supplied respiratory care equipment in hospitals. Phillipson EA: Lung volume dependence of pharyngeal cross-sectional area in patients with obstructive sleep apnea. 6. 5. ECRI Institute: Hazard report. Utsugi M. Laursen SB. Everett FM. Cleve Clin J Med 2010. Pigeot J. Boule´ M. 3. Dreijer B. Isono S. 77:705–14 13. 60: 1019 –24 14. 4. 26:169 –73 21. Simonds AK: Risk management of the home ventilator dependent patient. Lancet 2009. Sullivan CE: Obstructive sleep apnea: The use of nasal CPAP in 80 children. 55: 157– 64 12. The medical device design requirements developed by the Organization for International Standardization provide a framework to rationalize our choice of the medical device to support ventilation in the postoperative patient who has been supported with a domiciliary NIV system. Rouault S. Stenqvist O. Pelayo R. Simonds AK: Randomised controlled trial of non-invasive ventilation (NIV) for nocturnal hypoventilation in neuromuscular and chest wall disease patients with daytime normocapnia. Leger D. Lundin S. Roger G. Hill N: Non-invasive ventilation in acute respiratory failure. Anesthesiology 2012. Kettrick RG: Noninvasive ventilation via bilevel positive airway pressure support in pediatric practice. Nishino T: Comparison of static mechanical properties of the passive pharynx between normal children and children with sleep-disordered breathing. Theerakittikul T. Polkey MI. Heather S. ISO ⫽ Organization for International Standardization. Respiration 1998. 61:369 –71 3. Wilson JW. Am J Respir Crit Care Med 2001. Issa FG. Nørregaard O: Noninvasive ventilation in children. 9. Chatwin M. . Acta Anaesthesiol Scand 2011. Perrin C. J Pediatr 1995. 152:780 –5 17. Postoperative admission to the intensive care unit. 374:250 –9 2. Clerk A. Lofaso F: Chronic stridor caused by laryngomalacia in children: Work of breathing and effects of noninvasive ventilatory assistance. NIV ⫽ noninvasive ventilation. Thorax 2006. 6:52– 60 18. Liaison with the home ventilation program or responsible physician prior to discharge home. Jacobsen E: Bi-level positive airway pressure treatment of obstructive sleep apnoea syndrome. Crit Care Med 1998. Kotsimbos TC. Nava S. Lindgren S. 130:175– 8 10. Am J Respir Crit Care Med 1998. 163:540 –77 8. Young AC. Thorax 2011. Eves L: Reversal of obstructive sleep apnea by continuous positive airway pressure applied through the nares. Aboussouan LS: Noninvasive positive pressure ventilation for stable outpatients: CPAP and beyond. increase the collapsibility of the upper airway. Preoperative consultation with respiratory medicine. 20:1332– 42 9. Teague WG: Non-invasive positive pressure ventilation: Current status in paediatric patients. Table 2. Ward S. thereby compromising NIV therapy. Part 2. SomnoNIV Group: Ventilator modes and settings during non-invasive ventilation: Effects on respiratory events and implications for their identification. Fauroux B. tory system. 1:862–5 7. Berthon-Jones M. Waters KA. 127:905–12 16. Guilleminault C. Hemmingsen C. Managing the use of patient-supplied medical devices: Should patients be allowed their own medical devices in the hospital. Mehta S. Paediatr Respir Rev 2005. Ricaurte B. Health Devices 2007. Hill NS: Noninvasive ventilation. 65:114 –9 15. Rodenstein D. 155– 64 5. Recommendations for the Perioperative Management of Children Supported with Home Noninvasive Ventilation Therapy Recommendations 1. Transition to the home NIV system prior to discharge home. so too knowledge of biomedical design underlies the safe prescription of NIV medical devices. ECRI Institute: Guidance Article. Independent monitoring of the oxygen saturation and the cardiorespiratory status of the patient. Shimada A. 117:657– 68 667 Brown et al. Rabec C. Sullivan CE. Eur Respir J 2002. Gonzalez-Bermejo J. Hsiao K. 2. Hoffstein V. 66:170 – 8 6. 164: 1874 – 8 19. 157:1204 –12 11. Padman R. 41:652– 8 20. Bruderer JW. Konno A. Edwards EA. Lancet 1981. Zamel N. Am J Respir Crit Care Med 2001. NIV ⫽ noninvasive ventilation. Bocian RC: Home nasal continuous positive airway pressure in infants with sleep-disordered breathing. Support with the appropriate NIV system designed to enunciate the relevant alarm conditions. J Paediatr Child Health 2005. 38:417– 8 4. Am J Respir Crit Care Med 1995. Nixon GM: Paediatric home ventilatory support: The Auckland experience. Cle´ment A. Andersson B. Naughton MT: Ran- Fig. Leger P. Lawless ST. Am Rev Respir Dis 1984. Thorax 2005. Odenstedt Herge`s H: End-expiratory lung volume and ventilation distribution with different continuous positive airway pressure systems in volunteers. NIPPV ⫽ noninvasive positive pressure ventilation. Health Devices 2009. Decision tree for the selection of a medical device to deliver noninvasive positive pressure ventilation in the hospitalized postoperative patient. and alter the sensorium. Just as knowledge of pharmacology underlies the safe prescription of medication.

39. 43. Nicolai T: Risk factors for morbidity and mortality in pediatric home mechanical ventilation. Berry RB. Hess D. Combescure C. 41. Janssens JP: Monitoring of noninvasive ventilation by built-in software of home bilevel ventilators: A bench study. Navajas D: Potential rebreathing after continuous positive airway pressure failure during sleep. Cle´ment A. built-in ventilator software and autonomic markers of sleep fragmentation. 55: 1216 –29 Stucki P. 117:657– 68 35. Crit Care Med 2003. Schmidt H: Analysis of deaths related to anesthesia in the period 1996 –2004 from closed claims registered by the Danish Patient Insurance Association. Respir Med 2006. Ward DS. 29. 17:167–73 Kushida CA. Hiedi S. Tebe C. Marti S. Quan SF. Pe´pin JL. Scalfaro P. 50:237– 43 Farre´ R. Cotting J: Feasibility of non-invasive pressure support ventilation in infants with respiratory failure after extubation: A pilot study. de Halleux Q. Louis B: Are home ventilators able to guarantee a minimal tidal volume? Intensive Care Med 2010. 121:196 –200 Samolski D. Iber C. 2004 International Standard ISO-17510 –2: Sleep Apnea Therapy Part 2: Masks and application accessories. 31:1300 –7 Bunburaphong T. 36:1008 –14 Farre´ R. 141:469 –76 Gross JB. domised placebo controlled trial of non-invasive ventilation for hypercapnia in cystic fibrosis. Borel JC. Nishimura M. Respir Care 2010. Vignaux L. Brown LK. Pe´pin JL. Louis B: Performance of ventilators for noninvasive positive-pressure ventilation in children. 61:400 – 4 Brown et al. Rowley JA. Geneva. Lofaso F. 106: 675– 80 Janssens JP. capnography. Hoffmann F. 111:1050 – 60 Reiter K. Leroux K. Switzerland: International Organization for Standardization. Nickinovich DG. Giner J. 66:438 – 45 Contal O. 26. Ydens L. 31. Montserrat JM. Gozal D. Jolliet P. 2007 International Standard ISO-10651– 6: Lung ventilators for medical use: Particular requirements for basic safety and essential performance. 2004 International Standard ISO-10651–2: Lung ventilators for medical use: Particular requirements for basic safety and essential performance. Lofaso F. Pernath N. 40. Vermeulen F. Steinmetz J. Navajas D. 31:574 – 80 Antonescu-Turcu A. Casan P: Inspired oxygen fraction achieved with a portable ventilator: Determinant factors. Nava S: Where to perform noninvasive ventilation? Eur Respir J 2002. 25. Ballester E. Parthasarathy S: CPAP and bi-level PAP therapy: New and established roles. Connis RT.Noninvasive Ventilation Devices 22. 38. Geneva. Nicot F. 19:1159 – 66 Samuels M. Perez MH. ANESTHESIOLOGY 2006. Caplan RA. Escarrabill J: Performance of mechanical ventilators at the patient’s home: A multicentre quality control study. Switzerland: International Organization for Standardization. Gu ¨ ell R. SomnoNIV Group: Nocturnal monitoring of home non-invasive ventilation: The contribution of simple tools such as pulse oximetry. Cle´ment A. Leroux K. Benumof JL. 27. 668 Medicine: Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. 28. Schoen C. 34. 23. Pepin JL. 37. Lofaso F. Christoffersen JK. 2007 Essouri S. Chest 2012. Hess DR. Desmarais G. Cote´ CJ. Chest 1997. Kacmarek RM: Performance characteristics of bilevel pressure ventilators: A lung model study. Clin Pediatr (Phila) 2011. Pagel P. 35:1623–7 Fauroux B. Geneva. Thorax 2006. Eur Respir J 2008. Prachand V. Switzerland: International Organization for Standardization. Part 2: Home ventilators for ventilator-dependant patients. Geneva. Sanz F. Roger G. American Academy of Sleep Anesthesiology 2012. 24. Chest 2002. . Confalonieri M. Chatmongkolchart S. Intensive Care Med 2009. 104:1081–93 Schettino GP. Anton A. 100:1608 –13 Elliott MW. 4:157–71 Hove LD. Paediatr Child Health 2007. Thorax 2011. Part 6: Home-care ventilatory support devices. Garabedian EN. J Clin Sleep Med 2008. Bachenberg KL. Parthasarathy S. Bolt P: Non-invasive ventilation in children. 31:2178 – 82 Fauroux B. Switzerland: International Organization for Standardization. Imanaka H. Nielsen J. 63:72–7 International Standard ISO-17510 –1: Sleep Apnoea Therapy Part 1. Intensive Care Med 2005. 30. Kacmarek RM: Position of exhalation port and mask design affect CO2 rebreathing during noninvasive positive pressure ventilation. Fauroux B: Noninvasive positive pressure ventilation in infants with upper airway obstruction: Comparison of continuous and bilevel positive pressure. Isabey D. American Society of Anesthesiologists Task Force on Perioperative Management: Practice guidelines for the perioperative management of patients with obstructive sleep apnea: A report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. 32. Prats E. Montserrat JM. Yu S. Thorax 2008. ANESTHESIOLOGY 2007. Møller A. 36. Guell R. 33. Weaver EM. Chediak A. Positive Airway Pressure Titration Task Force. 42.