Non Invasive Ventilation

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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

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 Childrens 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 Childrens 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 Childrens 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 Childrens
Hospital, 2300 Tupper Street, Rm. C-1118, Montreal, Quebec H3H
1P3 Canada. [email protected]. 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

Noninvasive Ventilation Devices

deliver NIV therapy, and a specific discussion of management conundrums facing anesthesiologists. The discussion
focuses on children, because the use of NIV therapy in the
pediatric patient exposes the limitations of NIV systems.
However, these pediatric concerns may also be relevant to
small adults and patients with poor respiratory muscle
strength and reduced respiratory neural drive.
The technique of noninvasive ventilation has two unique
features that distinguish it from invasive ventilation with a
endotracheal tube. First, noninvasive ventilation employs a
nonhermetic technique, and the mask interface is deliberately designed to leak. Second, whereas invasive ventilation
bypasses the upper airway with a endotracheal tube, the noninvasive ventilation system incorporates the upper airway
into the breathing pathway.5 NIV modalities include continuous positive airway pressure (CPAP) and noninvasive positive airway pressure ventilation (NIPPV), both of which deliver a therapeutic positive airway pressure. NIPPV is also
referred to by the acronym NPPV (noninvasive positive pressure ventilation) and BiPAP (bilevel positive airway pressure), and BiPAP is also the name of a NIV medical device
manufactured by Philips Respironics (Murrysville, PA).

morbid obesity, respiratory muscle weakness may lead to


hypoventilation during both sleep and wakefulness. Hallmarks of hypoventilation during wakefulness are a chronic
compensated respiratory acidosis, i.e., daytime hypercapnia
with an increased serum bicarbonate level, and a low oxygen
saturation on room air during wakefulness. Management of
chronic hypercapnic respiratory failure with domiciliary
NIPPV in children with neuromuscular and chest wall disease is now standard practice.1219
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). Like
CPAP therapy, bilevel airway pressure therapy aims to
splint the pharyngeal airway and preserve lung volume.18
During inspiration, NIPPV therapy further augments airway
pressure by increasing inspiratory airflow in order to provide an
inspiratory assist to the muscles of respiration. Indeed, NIPPV
therapy in adult patients has been shown to improve tidal volume and minute ventilation by 33% and 17%, respectively.18
The use of NIPPV therapy during sleep enhances gas exchange
and decreases the work of breathing.13,20 Both exercise tolerance
and quality of life improve.21
As pulmonary function declines, respiratory support
during wakefulness may also be indicated. In the past,
children with deteriorating respiratory status were supported with a succession of increasingly complex medical
devices, culminating in tracheostomy and invasive ventilation. Parents and children currently may prefer to continue with NIPPV therapy, in order to avoid tracheostomy and thereby preserve phonation and swallowing
functions important to their quality of life. Children who
require both nocturnal and diurnal NIPPV are at very
high risk for respiratory complications, because their vital
capacity is usually less than 25% predicted, and they have
difficulty handling secretions.13 Failure of home NIV
therapy occurs more often in these children.2
Children requiring domiciliary NIPPV therapy are supported and managed in comprehensive home ventilation programs. Medical supervision is provided by sleep physicians and
respirologists who provide periodic review, including scheduled
overnight polysomnography studies. Therefore, preoperative
consultation with these physicians is important, because they
form the liaison with the home ventilation program.

An Overview of the Indications for Domiciliary NIV


Medical Indications for Home CPAP Therapy. In 1981,
Colin Sullivan introduced CPAP therapy as a modality to
reverse the symptoms of obstructive sleep apnea (OSA).6
CPAP therapy is currently widely prescribed for the management of OSA in adults and in children with OSA refractory
to adenotonsillectomy.7,8 During CPAP therapy, the positive airway pressure acts as a pneumatic splint for the pharyngeal airway.9 It also increases lung volume (i.e., functional
residual capacity).10 Both actions act to decrease the collapsibility of the upper airway and thereby mitigate obstruction
of the pharyngeal airway, offset auto-positive end-expiratory
pressure, reduce the load on respiratory muscles, and decrease the work of breathing. In adult patients, CPAP levels
of 5 and 10 cm H2O may increase tidal volume by 80 ml and
150 ml, respectively. CPAP therapy may also improve gas
exchange.11 In patients with coexistent pulmonary disease
and OSA, CPAP therapy may also improve lung function. In
patients with coexistent heart failure and OSA, CPAP therapy may improve cardiac function.12
Prescription of home CPAP therapy in children is reserved for those with OSA refractory to adenotonsillectomy.
Initiation of CPAP therapy usually involves a CPAP titration
study in a sleep laboratory. Once discharged home on CPAP
devices, children are followed in outpatient clinics, and their
management requires periodic review with overnight polysomnography. Preoperative consultation with the sleep physician or respirologist is important.
Medical Indications for Home NIPPV Therapy. 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. There are presently
more than two dozen brands of medical devices to deliver
NIV therapy,5 varying in biomedical design complexity from
simple sleep apnea equipment to sophisticated home and
critical care ventilators with NIV capabilities.
Regulatory bodies classify medical devices by risk. Class I
medical devices are not intended for use in sustaining or sup-

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uriCELEX:
31993L0042:EN:HTML. Accessed April 30, 2012.
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Table 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 175101: 2007


Class I

ISO 175101: 2007


Class I

ISO 106516: 2004


Class II

ISO 106512: 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, 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,
alarms are mandatory
More than $15,000

Less than $1,000

$2,000$5,000

$6,000

ISO Organization for International Standardization; USD United States dollars.

porting life and do not present a risk for injury. Examples of


Class I medical devices are stethoscopes, hearing aids and wheelchairs. Class II medical devices are intended to support life, are
required to meet mandatory performance standards, are designed to perform without causing injury, and are subject to
postmarket surveillance. Examples of Class II medical devices
are infusion pumps and ventilators. Medical devices to deliver
NIV therapy include both Class I and Class II medical devices.
(table 1) Class I medical devices are less expensive than Class II
ventilators, a reality that renders them cost-effective for home use.
Anesthesiology 2012; 117:657 68

The Organization for International Standards (ISO) and


the International Electrotechnical Commission, both worldwide networks of national standards institutes, develop international standards that provide the requirements for basic
safety and performance of medical equipment. These design
requirements provide a framework to compare the available
medical devices with those that deliver home NIV therapy
(table 1). Class I NIV devices comply with the standard, ISO
17510 Part 1.22 Class II ventilators with NIV capabilities
comply with ISO 10651 623 or ISO 106512.24 For the
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Brown et al.

Noninvasive Ventilation Devices

Fig. 1. Components of a single-limb circuit noninvasive


ventilation system. The exhaust port may be located in the
noninvasive ventilation mask or mask connection. Pressure and flow sensors are housed in the flow generator,
which also contains a pressure regulation valve. NIV
noninvasive ventilation.

purpose of this discussion, NIV systems complying with ISO


17510 Part 1 will be referred to as NIV devices. NIV systems
complying with ISO 10651 6 or ISO 106512 will be referred to as ventilators with NIV capabilities. The same ventilator may be equipped with both noninvasive and invasive
ventilation modalities.
The essential components of NIV systems are the flow
generator, the breathing circuit, and the NIV mask. (fig.
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. Whereas the driving
pressure for the flow generator in critical care ventilators is supplied from either pipelines, compressed gas, or air compressors,
in home NIV systems, it is supplied by a servo-controlled air
compressor.
Two different circuits double- and single-limb circuits
are available for use in NIV systems, as illustrated in figure
2.5 In double-limb circuits, there are separate inspiratory and
expiratory breathing pathways and an expiratory valve (fig.
2A). In single-limb circuits, the inspiratory and expiratory
breathing pathway share a common conduit. Single-limb
circuits lack an expiratory valve (figs. 2BC, BD), and in
single-limb circuits, the expiratory flow cannot be directly
measured. In double-limb circuits, the expiratory flow can
only be measured directly if the spirometer is interposed
between the expiratory valve and the patient (fig. 2A2).
Single-limb circuits are the usual circuit used to deliver
home NIV therapy.
NIV systems lack a reservoir bag, a design feature that
facilitates the delivery of a constant positive airway pressure
throughout the phases of the respiration. However, the absence of a reservoir bag requires a design that ensures an
adequate peak inspiratory flow rate. These design features
include a high rate of gas flow and/or an alternate inspiratory
pathway. In normal operation, the level of inspiratory gas
flow delivered through the breathing tube ranges from 20 to
60 l/min.
The NIV mask complies with ISO 17510 2.25 The
NIV mask is used interchangeably with Class I NIV deAnesthesiology 2012; 117:657 68

Fig. 2. Essential components of noninvasive ventilation (NIV)


systems using double (AA, AB) and single (BD, BC) circuits.
In all systems, 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, AB) or
exhaust port (BC, BD). When applied to the face, this results
in an intentional leak and pressurizes the NIV system. Expiratory airflow is only measurable when the flow meter is
located between the patient and the expiratory valve (A2). In
the three other configurations, expiratory airflow cannot be
measured directly. NIV noninvasive ventilation. Reproduced with permission from Rabec et al.,5 modified from
Perrin C, Jullien V, Lemoigne F: Aspects pratiques et techniques de la ventilation non invasive. Rev Mal Respi 2004;
21(3):556 66.

vices and Class II ventilators with NIV capabilities. 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. The exhaust port discharges a continuous intentional leak during
normal operating conditions. In addition, the imperfect
seal of the mask to the face is an additional source of
leakage: the unintentional leak. The magnitude of the
unintentional leak varies with the phase of respiration,
with shifts in the mask position and with changes in the
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compliance and resistance of the upper airway and respiratory system. 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.
Although NIV systems will fit a 15 mm/22 mm connector, they are not intended for use with tracheal tubes. The
leak around an invasive uncuffed tracheostomy tube is insufficient to adequately discharge the high rate of inspiratory gas
flow, in excess of 20 l/min, without injury. Home ventilators
for invasive ventilation are indicated in tracheostomized
patients.23
NIV systems have three additional design features. First,
all NIV devices are equipped with a pressure sensor located in
the flow generator to detect high airway pressure. Second, 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).
And third, home NIV devices are intended for dedicated use
in single patient and are not designed to function with in-line
filters.
CPAP Devices. CPAP devices are designed to deliver a
continuous distending pressure throughout the patients
respiratory cycle.26 The minimum performance for the
delivery of positive airway pressure is 1.5 cm H2O of
the set pressure.22,27
NIPPV Systems. NIPPV devices are designed to deliver a
cyclical application of two levels of positive pressure: IPAP
and EPAP. This requires design features that sense the phase
of respiration8,26 and trigger the transitions between IPAP
and EPAP.

The sensitivity of the trigger function represents an important limit to the use of NIPPV in small children, particularly those with poor respiratory muscle strength,18,26,28
because their low rates of inspiratory flow may be insufficient
to initiate the inspiratory trigger.8 This is one of the reasons
NIV devices are not intended for use in patients weighing less
than 30 kg. For these children, ventilators with NIV capabilities offer a better option.
Pressure-targeted NIPPV Systems
Most bilevel pressure NIV systems achieve the IPAP level by
increasing the rate of gas flow during inspiration, until the
predefined positive airway pressure target is attained. It is
beyond the scope of this review to discuss all NIV modalities,
and readers are directed to a comprehensive review in Thorax.5 The two basic NIV modalities are pressure-targeted
NIPPV and volume-targeted NIPPV. The majority of home
NIV systems use pressure-targeted modalities.
The EPAP is titrated to eliminate obstructive airway
events, and IPAP is titrated to attenuate hypercarbia during
sleep. The usual levels of IPAP and EPAP range from 10 to
16 cm H2O and from 4 to 5 cm H2O, respectively. NIPPV
devices have less pressure-generating capacity than ventilators.7 The magnitude of inspiratory assist depends on the
difference between IPAP and EPAP.18 However, the NIV
systemlung assembly does not behave as a single compartment model, because the upper airway presents a variable
resistance. Increasing the airway pressure may not increase
the effective ventilation to the patient.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. 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.8 These
gas flow rates may exceed 150 l/min.

The Inspiratory Trigger between EPAP and IPAP


The trigger for IPAP is initiated by the patients inspiratory effort and is detected by a change in airway pressure
or gas flow within the NIV system.5 Most modern NIV
systems achieve the transitions between IPAP and EPAP
with flow-based triggers. Sophisticated proprietary algorithms have been developed to detect phasic changes in gas
flow, gas waveforms, and flow reversal(s). Asynchrony between the child and NIV system during the inspiratory
trigger is common especially during sleep, and therefore
some homecare NIV protocols require a backup ventilation rate. The selected backup rate is often set at a rate
higher than the childs spontaneous rate during sleep, effectively instituting a controlled mode of ventilator support.8 NIV devices, however, are not intended for use in
apneic patients (table 1).

The Interface and the NIV Mask


NIV therapy is delivered with a nasal or full-face mask. The
NIV mask design is deliberately nonhermetic, allowing the
mask to be adjusted to comfort. The mask must be soft and
secure and yet allow for sweating. Velcro straps applied too
tightly to a full-face mask may displace the mandible backward, allowing the tongue to obstruct the upper airway.8 In
addition, a tight, ill-fitted mask risks skin injury and ulceration. Too tight a mask, worn over many years, may adversely affect the growth and development of facial bones.1
Although the patient connection port may be a 15 mm/22
mm connector,22,25 NIV systems are not designed for use
with a endotracheal tube, tracheostomy tube, laryngeal
mask, or anesthesia mask. If the expiratory trigger failed and
the high inspiratory gas flow continued during expiration,
the patient could become hyperinflated, risking barotrauma
and injury.

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.8 In children, a maximum inspiratory time of 0.3 0.5 s is often used.
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Noninvasive Ventilation Devices

Fig. 3. Representative tracing showing the response to a noninvasive ventilation system with a minimum guarantee mode to
a perturbation. The inspiratory positive airway pressure increased in order to achieve the minimum guaranteed tidal volume. The
onset and offset response times ranged from 1 to 51 breaths. The tidal volume decreased transiently during the onset and
increased transiently during the offset. The specific responses to three types of perturbations are shown in the accompanying
table. IPAP inspiratory positive airway pressure; NIV noninvasive ventilation; VT tidal volume. Adapted from Fauroux et
al.29 and reprinted with permission.

breath cycle without the patient triggering a breath, occurred


frequently during large unintentional leaks. In addition, a
large unintentional leak may preclude attainment of the preset IPAP, and the NIV system may not cycle to EPAP,8,18
allowing the high rate of gas flow to continue even if the
patient ceases to inhale. This high gas flow rate will impede
exhalation, increasing the work of breathing and risking
barotraumas, gastric insufflation, and aspiration of stomach
contents. Large unintentional leaks at the mask interface are
particularly common in children.

For children, nasal masks are preferred, in part to minimize the apparatus dead space and facilitate the trigger functions of the NIV systems. During normal operation, mouth
breathing increases the gas leakage, and parents may devise
ways and means to ensure the mouth remains closed during
sleep (i.e., chin straps).
In pressure-targeted NIV systems, the magnitude of the
inspiratory assist decreases during perturbations such as increased upper airway resistance, decreased lung compliance,
or increased unintentional leak. Modern NIV systems offer a
volume guarantee mode that will deliver a minimum level
of ventilation when such perturbations occur. The efficacy of
the volume guarantee mode was recently tested in six NIV
systems.29 Perturbations sufficient to decrease tidal volume
(VT) were determined. The ventilators were set in the volume guarantee mode to deliver a minimum VT. The response to a perturbation was to increase IPAP (fig. 3). With
perturbations in airway resistance or lung compliance, five of
six NIV systems achieved the guaranteed minimum VT.
However, when the unintentional leak increased, only one
NIV system achieved it. Auto-triggering, or the delivery of a
Anesthesiology 2012; 117:657 68

Rebreathing Potential in NIV Devices


Although the ECRI Institute considers the patient-supplied
NIV mask less hazardous than the NIV device, it is the design
of the NIV mask that influences the risk of rebreathing.
Washout of carbon dioxide is more efficient if the exhaust
port is located within the mask.4,5
Dual-limb NIV systems mitigate the degree of rebreathing by using an expiratory valve and separating the inspiratory and expiratory pathways.5 In a single-limb NIV system,
the inspiratory and expiratory breathing pathway share a
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Fig. 4. Gas pathway in noninvasive ventilation system using a


single-limb circuit. During normal use, the flow generator
directs air into the breathing tube, which contains an admixture of fresh and exhaled gas. 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).

common conduit (fig. 4). As the exhaust port purposely offers a high resistance, the expiratory pathway may include the
low-resistance breathing tube. A high rate of gas flow is required to prevent rebreathing during normal use.30 The risk
of rebreathing decreases with increasing airway pressure
(higher gas flows). The NIV systems are designed such that
during normal use, the time-weighted average for inspired
carbon dioxide is 1%, a limit which harmonizes with that
allowed in occupational health exposure.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.
The risk of rebreathing is maximal when inspiratory gas
flow ceases. In the event of a power failure, the inspired
carbon dioxide level will rise precipitously, coincident with a
fall in inspired oxygen (fig. 5). Although a battery reserve
should protect from electrical power failure, battery life is
difficult to predict and often brief. Class I medical devices
may not be equipped with a battery backup. Therefore, the
design of NIV equipment incorporates a means to allow
spontaneous breathing in the event of a device failure. This
may be accomplished by including an antiasphyxiation valve
in the NIV mask. A nasal NIV mask should have less risk of
asphyxiation because the child can initiate mouth breathing.
However, mouth breathing may not be possible if chin straps
are used. In NIV systems, the short-term exposure limit for
inhaled carbon dioxide is 3% (about 22 mmHg), a limit that
assumes that the physiologic arousal response will be sufficient to rouse the patient.22,25

Fig. 5. Rebreathing potential in noninvasive ventilation systems. During normal use, elimination of exhaled carbon dioxide depends on a high rate of gas flow. In the conventional
continuous positive airway pressure system (A), an electrical
power-off scenario results in rebreathing of exhaled gas.
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.
NIV noninvasive ventilation. Reproduced with permission
from Farre et al.30

tion, including the NIV modality, the rate of gas flow rate,
the minute ventilation, and the location at which oxygen is
delivered into the NIV system. In healthy volunteers on NIV
therapy, a maximum inspired oxygen concentration of 67% was
reported.31 However, the inspiratory oxygen concentration
achieved in patients on NIV devices is often less than 50%.
Perioperative Management Conundrums in Patients
Supported with Domiciliary NIV
Patient Selection. The safe use of NIV to support ventilation following surgery requires selection of both appropriate patients and NIV systems, and a recognition that the
clinical scenario in the hospital differs from that in the
home environment.
In hospitalized patients, eligibility criteria for NIV support are the ability to call for help, to pass 15 min off NIV
without respiratory decompensation, and to maintain oxygen saturation with modest inspired oxygen concentrations.1,32 Health Canada advises that patients who have a
limited ability to adjust or remove the NIV mask should be
attended at all times.# NIV therapy is contraindicated if
children are apneic, unable to protect their own airway, unable to maintain the patency of the upper airway, have a
reduced level of consciousness, or have an unstable respiratory status.33

Inspired Oxygen Concentration


During power failure, with cessation of gas flow, the rebreathing of exhaled gases will allow a hypoxic admixture to
accumulate in the breathing tube (fig. 5).30 In the event of a
power failure, it is expected that the sleeping patient will
rouse and remove the NIV mask.
During normal use, supplemental oxygen may be intentionally delivered into the breathing tube or the mask interface. 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). These

# http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/
index-eng.php. Accessed April 30, 2012.
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Noninvasive Ventilation Devices

intravenous sedation. The respiratory status further deteriorated, requiring invasive ventilation.17
Because NIV devices are used in a home environment,
their use on hospital wards might seem reasonable. However,
mishaps during NIV therapy have been reported in hospitalized patients. In one case, the CPAP device was misassembled.35 Another patient died because of NIV system failure, and a third death was linked to NIV system-related
infection.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.# The
safe use of NIV therapy on the wards requires the selection of
patients with stable respiratory failure, the availability of expert and adequately trained staff throughout a 24-h period,
adequate monitoring, and immediate access to invasive ventilation in the event of respiratory deterioration.1,32
In addition, the settings for NIV systems that are adequate in the home environment may not be therapeutic in
the postoperative period, as illustrated in figures from three
consecutive nocturnal NIV recordings (figs. 7 and 8). Figure
7A is a representative baseline trace of internally logged data
from a home NIV system; the set EPAP and IPAP levels of 4
and 15 cm H2O, respectively, were achieved throughout
13 h of use. During the majority of the record, there were no
patient-triggered breaths, and ventilation was supported entirely with the NIV system, at a backup rate of 25 breaths/
min. The estimated tidal volume was 277 ml and the estimated minute ventilation was 6.8 l/min. Following surgery
(fig. 7B), the set EPAP and IPAP levels were identical and
achieved throughout 18 h of use. However, patient-triggered
breaths are now present throughout the record, likely reflecting a combination of wakefulness and pain. The recorded
tidal volume has decreased to 202 ml. During the following
night (fig. 8), the set EPAP and IPAP levels were unchanged
and achieved throughout the 22 h of use, but the recorded
tidal volume has now decreased to 98 ml. The levels of positive airway pressure, which were therapeutic in the home
environment, are now inadequate.

Fig. 6. Discharge criteria for patients supported with home


continuous positive airway pressure devices.

NIV systems rely on the patients reflex and arousal mechanisms to monitor the function of the NIV system. Sedative
and analgesic medication may blunt arousal and reflex defenses. Because the safe use of NIV systems is predicated on
an intact physiologic defense system, children on domiciliary NIV systems should not be discharged home until
these protective and defense mechanisms have returned13
(fig. 6). Children with continuous home NIPPV therapy
have a limited respiratory reserve and are at extreme risk
for respiratory complications following anesthesia and
surgery. These children are poor candidates for ambulatory programs.13
Which Surgical Procedures?
As NIV systems include the upper airway in the breathing
pathway, compromise of nasopharyngeal airway patency
may limit the efficacy of NIV therapy. Surgeries associated
with upper airway edema, bleeding, nasal congestion, and
surgical packings may obstruct the upper airway, and affect
the efficacy of NIV therapy. Pulmonary function may be
affected in the postoperative period, and supplemental oxygen may be required. In addition, the settings for the NIV
system may require adjustment. IPAP levels of 10 16 cm
H2O usually provide sufficient support. Children become
uncomfortable if IPAP settings exceed 20 cm H2O.18 The
maximum IPAP for preadolescent children is 20 cm H2O,
and for adolescents the maximum is 30 cm H2O.34 Higher
levels of IPAP may increase the gas leak, and the straps securing the NIV mask may require adjustment.

Monitoring and Alarms: Do NIV Systems Monitor


Ventilation?
All NIV systems are required to measure airway pressure, and
the majority of modern NIV systems log parameters of airway
pressure for periodic review. However, a data log is not synonymous with a monitor. Class I medical devices are not designed
to monitor patients, and patient well-being is the prime indicator that an NIV device is functioning. A feature that distinguishes the Class II NIV systems from Class I NIV devices is the
requirement, in the former, to monitor the ventilation of the
patient (table 1). Class II ventilators for ventilator-dependant
patients are intended to deliver both positive airway pressure
and ventilation and are therefore designed appropriately.24
Home ventilation programs define ineffective ventilation
by the failure to attain the set airway pressures, an excessive

Can NIV Be Safely Administered on Hospital Wards?


Expertise of Healthcare Providers. The challenges of delivering NIPPV therapy on hospital wards are illustrated by two
published scenarios in patients with advanced cystic fibrosis.
An adolescent on continuous NIPPV was found unresponsive on the floor, having removed the NIPPV system without
notifying his nurse. A young adult with chronic respiratory
failure developed agitation because of respiratory acidosis.
Trigger asynchrony was suspected, and she was treated with
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Fig. 7. Representative figures illustrating the limitations of a noninvasive positive pressure ventilation system in the hospital
environment. In both the home (A) and hospital (B) use scenarios, the set levels of inspiratory positive airway pressure and
expiratory positive airway pressure were identical. However, the efficacy of the ventilatory support differed. EPAP
expiratory positive airway pressure; IPAP inspiratory positive airway pressure; NIPPV noninvasive positive pressure
ventilation.

unintentional leak, and frequent desaturation indices.36


Capnography is not used in the home environment. Some
manufacturers have developed sophisticated proprietary algorithms that assess gas flows and estimate the unintentional
leaks of the NIV system. In addition, there are proprietary
algorithms that estimate the delivered minute ventilation
and VT of the patient. However, the accuracy and clinical
relevance of the reported physiologic parameters lack validation. Recent bench studies suggest that VT is underestimated, especially at high IPAP pressures.37 In the home environment, there is no need for bedside reporting of data,
because the efficacy of the NIV therapy is assessed by patient
well-being and periodic review of the internally logged data.
In hospitalized patients it may prove useful to review this
internally logged data, but currently this feature is not readily
available at the bedside.

ment of carbon dioxide may be more useful in the hospital


environment.36
Should Children Be Permitted the Use of Their Own
Domiciliary NIV Systems?
Of the task forces consultants charged with developing
guidelines for the perioperative management of patients with
OSA, 79% strongly agreed that patients should be restarted
on their home NIV therapy as soon as feasible after surgery.38
Parents and children often request the use their own NIV
system while in the hospital, citing differences among NIV
systems in leakage, trigger sensitivities, type of circuit, and
position of the exhaust port all of which may affect the
quality of ventilatory support.39 41 In the home environment, the NIV systems are reported to be robust and reliable,8,33,42 and this request may seem reasonable. However,
whereas the use of patient-supplied NIV masks is condoned,
the ECRI Institute cautions hospitals against the use of patient-supplied NIV systems.3,4
Most countries lack a centralized database for reporting
problems with home NIV systems.2 The lack of reporting is
not evidence of safety, as Health Canada cautions that rates
for spontaneously reported adverse incidents (with NIV
systems) are presumed to underestimate the risk.# A multicenter evaluation of 22 conventional NIV systems reported significant differences between the set parameters
and the actual values. In 17% of patients, the index of
ventilator error exceeded 20%. In addition, home NIV
systems underperform when subjected to high-level re-

If Patients on Domiciliary NIV Are Not Being Monitored


at Home, Do They Need to Be Monitored While in the
Hospital?
Unless the ventilation is being monitored at the bedside,
changes in the ventilatory status may not be obvious.
Health Canada advises that hospitalized patients supported
with NIV systems must be monitored with oxygen saturation
and vital signs.# Arterial or capillary blood gases may also be
indicated. Although capnography is available in hospitals, its
accuracy in NIV systems may be influenced by dead space,
VT, and the high rate of gas flow. Transcutaneus measureAnesthesiology 2012; 117:657 68

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Noninvasive Ventilation Devices

Fig. 8. Representative figure in a postoperative scenario showing the limitation of the same noninvasive positive pressure ventilation
system illustrated in Fig. 7. The set levels of inspiratory positive airway pressure and expiratory positive airway pressure remain
unchanged from those in figs. 7A and 7B; however, the level of ventilatory support is much lower. EPAP expiratory positive airway
pressure; IPAP inspiratory positive airway pressure; NIPPV noninvasive positive pressure ventilation.

their perioperative management. The optimal transition


from sedation and/or general anesthesia to their home NIV
system is an area of study, and practice guidelines for the safe
management of patients supported with home NIV systems
have yet to be developed. Our recommendations are listed in
table 2. As the intensive care unit is the only location in our
hospital with continuously available expertise in NIV systems, all children requiring NIV therapy in the postoperative
period are initially admitted to the intensive care unit following anesthesia. Our caseload of the children on home NIV
therapy is small, and this requirement has not proven problematic. Recovery of both defensive and protective reflexes
and transition to the home NIV system should occur before
discharge from hospital.

quirements similar to those which may occur during the


postoperative period.43
Another major issue with patient-supplied NIV systems is
that the alarms have frequently been disabled, because most (i.e.,
low VT) enunciate so frequently they constitute a nuisance and
disrupt sleep.33,43 A feature that distinguishes the Class II NIV
systems from Class I NIV devices is the requirement, in the
former, to enunciate alarm conditions intended to summon
help (table 1). Disabling alarms on ventilators with NIV capabilities negates the safety design features that distinguish Class II
from Class I medical devices. In the postoperative period, when the
patients clinical state may change rapidly, ventilators with NIPPV
capabilities, which are designed for ventilator-dependant patients,
may provide more reliable respiratory support. At some point before discharge, transition to a domiciliary NIV system and liaison
with the home ventilation program is required (fig. 9).

Summary
Treatment of refractory obstructive sleep apnea and chronic
respiratory failure with home NIV is now standard pediatric
practice. Anesthetic and analgesic medications induce apnea,
depress respiratory drive, decrease compliance of the respira-

Recommendations
Anesthesiologists increasingly encounter children who are
supported on home NIV therapy and are asked for advice on
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Fig. 9. Decision tree for the selection of a medical device to


deliver noninvasive positive pressure ventilation in the hospitalized postoperative patient. ISO Organization for International Standardization; NIPPV noninvasive positive pressure ventilation; NIV noninvasive ventilation.

tory system, increase the collapsibility of the upper airway,


and alter the sensorium, thereby compromising NIV therapy. Just as knowledge of pharmacology underlies the safe
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Table 2. Recommendations for the Perioperative


Management of Children Supported with Home
Noninvasive Ventilation Therapy
Recommendations
1. Preoperative consultation with respiratory medicine.
2. Postoperative admission to the intensive care unit.
3. Support with the appropriate NIV system designed
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4. Independent monitoring of the oxygen saturation
and the cardiorespiratory status of the patient.
5. Transition to the home NIV system prior to
discharge home.
6. Liaison with the home ventilation program or
responsible physician prior to discharge home.
NIV noninvasive ventilation.
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Noninvasive Ventilation Devices

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