Health Policy Advisory Committee on
Technology
Technology Brief
Non-Invasive Open Ventilation (NIOV™) System for
Respiratory Insufficiency
April 2016
© State of Queensland (Queensland Department of Health) 2016
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DISCLAIMER: This Brief is published with the intention of providing information of interest. It is
based on information available at the time of research and cannot be expected to cover any
developments arising from subsequent improvements to health technologies. This Brief is based on
a limited literature search and is not a definitive statement on the safety, effectiveness or costeffectiveness of the health technology covered.
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This Brief was commissioned by Queensland Health, in its role as the Secretariat of the Health Policy
Advisory Committee on Technology (HealthPACT). The production of this Brief was overseen by
HealthPACT. HealthPACT comprises representatives from health departments in all States and
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This brief was prepared by Dr Meegan Vandepeer from ASERNIP-S.
Summary of findings
The Non-Invasive Open Ventilation (NIOV™) system by Breathe Technologies Inc. (California,
USA) is a lightweight, wearable ventilation system. Outcomes from one randomised
controlled trial and two non-randomised comparative studies on the NIOV system are
described in this Brief. The randomised controlled trial was in the form of a meeting
abstract. At least one of the comparators in each study was standard oxygen therapy using a
cannula.
Overall, the three studies reported positive results for the NIOV system. The two nonrandomised comparative studies investigated the effects of the NIOV system on exercise
tolerance. Of the two studies, one reported significant improvement in all outcomes
measured (dyspnoea, endurance, fatigue, discomfort and arterial oxygen saturation), while
the other reported significant improvements in endurance, heart rate, arterial oxygen
saturation and activation of respiratory muscles, but no improvement in dyspnoea. The
randomised controlled trial reported improvements in dyspnoea, however, less
improvement in average 6-minute walk test distance for the NIOV system compared with
the standard oxygen with cannula treatment.
Several factors need to be taken into account when considering the above results. Sample
sizes were small, with the largest study enrolling only 30 patients. One of the nonrandomised comparative studies included only men, limiting the generalisability of its
results. All studies described in this Brief comprised patients with chronic obstructive
pulmonary disease (COPD). It should be noted that Breathe Technologies, Inc. states that
indications for the NIOV system include COPD, interstitial lung disease (ILD), neuromuscular
conditions and pre- and post-lung transplantation. The safety and efficacy of the NIOV
system for other populations is unknown. A range of conflicts of interest were reported in
two of the studies, including sponsorship by Breathe Technologies, Inc.
HealthPACT Advice
The Non-Invasive Open Ventilation (NIOV™) system has the potential to support people with
COPD outside of a hospital environment, increasing their mobility and quality of life.
Treatment with the NIOV™ system may offer an opportunity for clinical redesign that
reduces or avoids hospital admissions and readmissions.
Due to the lack of data from large, long-term comparative studies, HealthPACT does not
recommend public investment in this technology at this time. However, HealthPACT
recommends the evidence for the NIOV™ system be reviewed in 24 months.
Non-invasive open ventilation (NIOV™) system: April 2016
i
Technology, Company and Licensing
Register ID
WP193
Technology name
Non-Invasive Open Ventilation (NIOV™) system
Patient indication
Adult patients with respiratory insufficiency resulting from
conditions such as chronic obstructive pulmonary disease,
interstitial lung disease and neuromuscular conditions.
Description of the technology
The NIOV system is a non-invasive, positive pressure ventilator (NIPPV) that provides a
mixture of oxygen and air when required for patients with respiratory insufficiency. The
device was developed as a wearable ventilation system (weighing only 454 g), with the aim
of improving exercise tolerance and reducing dyspnoea (breathlessness) for affected
patients. It is intended for use by adults capable of spontaneously breathing a minimum
tidal volume of 3.5 mL per kg of predicted body weight. It is not indicated for patients who
cannot spontaneously breathe, or those who are fully dependent on mechanical
ventilation.1
The NIOV system consists of a purge tube, oxygen cylinder, oxygen regulator, oxygen supply
hose, ventilator, belt clip, battery charger and an open, non-sealing, proprietary nasal pillow
interface that leaves the mouth unobstructed (available in four sizes). The oxygen cylinder is
not supplied with the device. The system requires a 50 psi oxygen source with a minimum
flow of 28 L per minute. Breathe Technologies Inc. advises that the oxygen regulator
provided with the NIOV system works with most oxygen cylinders. The battery can be recharged at any 12 V outlet, such as those available in cars, and lasts for approximately four
hours.1-3
The ventilator system can be worn on a patient’s belt or slung over the shoulder.1 When
triggered by the patient breathing in (inspiration), the system delivers a pre-set bolus of
oxygen (ranging from 50 to 250 mL in volume) according to the patient’s requirement. In
addition, ambient air is drawn in through two ports located on the nasal pillow interface.
Depending on the volume setting, and factors such as lung compliance and resistance, the
total volume of oxygen plus ambient air delivered can exceed 450 mL. Ventilator inspiratory
time is set as a function of the patient’s total breath cycle time.4
Intended applications of the NIOV system include assisting patients to walk and undertake
physical, occupational or respiratory therapy or other rehabilitation activities in an
institutional or home environment. It should be operated by trained personnel, or by
patients or their caregivers under the direction of a physician.1
Company or developer
Breathe Technologies Inc., California, USA.
Non-invasive open ventilation (NIOV™) system: April 2016
1
Reason for assessment
The NIOV system is an innovative development in non-invasive ventilation for people with
respiratory insufficiency. The wearable system is much smaller and lighter than other noninvasive ventilators (454 g compared to 4.5—5.4 kg), enabling patients to move about freely
and participate in daily activities, thereby aiding the recovery process.5
Stage of development in Australia
Yet to emerge
Established
Experimental
Established but changed indication
or modification of technique
Should be taken out of use
Investigational
Nearly established
Licensing, reimbursement and other approval
The NIOV system has received 510(k) approval (K1311562) from the United States Food and
Drug Administration and the European CE mark.6, 7
Australian Therapeutic Goods Administration approval
Yes
ARTG number (s)
No
Not applicable
Technology type
Device
Technology use
Therapeutic
Patient Indication and Setting
Disease description and associated mortality and morbidity
Breathe Technologies Inc. state that the NIOV system is designed for people with respiratory
insufficiency (that is a reduced ability to perform gas exchange) resulting from conditions
such as chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD) and
neuromuscular conditions, and for patients before and after lung transplantation.8
The reduced ability to perform gas exchange is also termed ‘respiratory failure’. There are
two types of respiratory failure; type one is when not enough oxygen transfers from the
lungs into the blood (hypoxaemia); type two is when your lungs can’t remove sufficient
carbon dioxide from your blood (hypercarbia). Both of these conditions can occur at the
same time.9 Type one is the most common form of respiratory failure, and can be associated
with nearly all acute diseases of the lung which generally involve fluid filling or collapse of
alveolar units. Causes of type two respiratory failure include drug overdose, neuromuscular
Non-invasive open ventilation (NIOV™) system: April 2016
2
disease, chest wall abnormalities, and severe airway disorders (for example, asthma and
COPD).10
COPD
COPD is a common preventable and treatable disease, characterised by persistent airflow
limitation that is usually progressive and associated with enhanced chronic inflammatory
responses in the airways and the lungs to noxious particles or gases.11 The most common
COPD conditions are emphysema (damaged alveoli and bronchi), chronic bronchitis
(inflammation of the bronchi) and chronic asthma that isn’t fully reversible with the use of
medication.12
Usually COPD develops so slowly that people are unaware that their breathing is affected.
By the time the main symptoms of breathlessness, chronic cough and sputum production
appear, considerable lung damage has already occurred. Some people with COPD have to
reduce their physical activity due to breathlessness. With progression of the disease, simple
activities like showering, dressing or making a cup of tea become extremely difficult.12
Smoking is the main cause of COPD. Other causes include outdoor air pollution, workplace
fumes and dust, childhood respiratory infections, and smoke from burning fuels. There is no
cure for COPD, and the damaged lung tissue does not repair itself. Diagnosis is based on a
breathing test called spirometry. Other tests that may be conducted include physical
examination, blood tests, sputum analysis, chest x-ray and CT scans.12, 13
ILD
ILD refers to a large group of conditions affecting the lung’s interstitium, the network of
tissue that provides support to the microscopic air sacs (alveoli). All forms of ILD cause
thickening of the interstitium. The thickening can be due to inflammation, scarring or fluid
accumulation. Some forms of ILD are short-lived; others are chronic and irreversible.14
The primary signs and symptoms of ILD include a dry cough and shortness of breath at rest
or with exertion. ILD can lead to a series of life-threatening complications including acute
exacerbation of respiratory insufficiency, high blood pressure in the lungs (pulmonary
hypertension), an abnormally low oxygen level in the blood (hypoxaemia) and respiratory
failure. Once lung scarring occurs it is generally irreversible. Medications may slow the
damage, but many people never regain full use of their lungs.15
Some types of ILD are caused by inhaling dust or other particles in the air (e.g. coal dust,
asbestos, farm dust and silica dust). Other causes of ILD include autoimmune diseases or
exposure to moulds, gases or fumes. In some cases the cause of ILD is unknown. 16 Diagnosis
can include imaging tests (e.g. chest x-ray, computerised tomography scan and
echocardiogram) and pulmonary function tests (e.g. oximetry and spirometry).15
Non-invasive open ventilation (NIOV™) system: April 2016
3
Neuromuscular conditions
Diseases that affect the neuromuscular system are classified into four main groups: motor
neurone diseases, neuropathies, neuromuscular junction disorders, and myopathies,
including muscular dystrophies. There are a range of causes for these conditions including
genetic abnormalities, viral infections, autoimmune disorders, metabolic disorders, dietary
deficiencies, and certain drugs and poisons.17
Some neuromuscular conditions can result in respiratory muscle weakness, which can cause
breathing difficulty and coughing. Symptoms, which may not become apparent until there is
a complication (e.g. lung infection), can include recurrent chest infection, chronic headache,
constant fatigue and increased muscle weakness.18
Neuromuscular conditions are diagnosed using a range of tests including nerve conduction
studies, electromyography, blood tests, muscle biopsies and genetic testing.17
Number of patients
COPD
In 2012, COPD caused 5,923 deaths in Australia, making it the fifth leading cause of death.19
An estimated 530,000 Australians had COPD in 2011-12.20 In New Zealand, COPD is the
fourth most common cause of death, and was responsible for an estimated 12,000 hospital
admissions and greater than 50,000 bed-days in 2011. In New Zealand, COPD affects an
estimated 15 per cent of the adult population over the age of 45 years (at least 200,000
people).21, 22
ILD
No statistics could be identified on the incidence or prevalence of ILD in Australia or New
Zealand. Based on registries in other countries, the estimated incidence of ILD in Australia is
30 in 100,000 people per year.23
Neuromuscular conditions
It is estimated that there are greater than 20,000 people in Australia who have some form
of neuromuscular disease.24 An estimate of the number of people with neuromuscular
conditions in New Zealand could not be found.
Speciality
Respiratory medicine
Technology setting
Multiple, including general hospital, community and
ambulatory care
Non-invasive open ventilation (NIOV™) system: April 2016
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Impact
Alternative and/or complementary technology
The NIOV ventilation system is a substitute for other NIPPV (non-invasive, positive pressure
ventilator systems).
Current technology
The NIOV system is a type of NIPPV. These devices deliver a mixture of air and oxygen
through a non-invasive interface (nasal mask, face mask or nasal plugs) rather than via a
breathing tube (endotracheal or tracheostomy tube).25 The ventilator helps or does the
work of the respiratory muscles by exerting a positive pressure on the airways during
inhalation.
Collectively, NIPPV includes several modalities of non-invasive ventilation that can be
delivered via a standard intensive care unit ventilator or a portable device like the NIOV
system.25 There is a wide range of portable ventilators currently on the market, however,
the NIOV system is reported to be the first and only wearable form of portable NIPPV
ventilator to receive CE mark and FDA approval.26, 27
Diffusion of technology in Australia
At the time of writing this Brief there was no evidence that the NIOV system is being used in
Australia.
International utilisation
According to Breathe Technologies, Inc., the NIOV system is currently being used by
clinicians and patients across the USA in public and private hospitals, Veterans Affairs
healthcare facilities, pulmonary rehabilitation centres and in patients’ homes.28
Country
Level of Use
Trials underway or
completed
USA
Limited use
Widely diffused

Cost infrastructure and economic consequences
The only expected cost of the NIOV system is the cost of the device. The manufacturer were
contacted regarding the cost of the device but did not respond. There are no infrastructure
costs. Regarding costs to the healthcare system, one meeting abstract was identified that
included a retrospective study describing changes in healthcare utilisation before and after
NIOV implementation in 16 patients with chronic respiratory insufficiency.29 The study
reported that the number of emergency department visits, inpatient admissions, inpatient
days and intensive care unit days significantly decreased following NIOV implementation.
Non-invasive open ventilation (NIOV™) system: April 2016
5
Although the study was retrospective and involved only a small number of patients, it
indicates that the NIOV system may result in reduced costs to the healthcare system.
The NIOV system may be an alternative treatment option for COPD presentation in the
Intensive Care Unit setting. This may result in reduced healthcare costs.
Ethical, cultural, access or religious considerations
No ethical, cultural, access or religious considerations were identified that may limit the use
of this technology.
Evidence and Policy
Safety and effectiveness
One randomised controlled trial (level II interventional evidence) reported in a meeting
abstract and two non-randomised comparative studies (two level III-2 interventional
evidence) were identified for inclusion in this Technology Brief. An abstract detailing the
longer term results of a subset of patients from one of the non-randomised comparative
studies is also summarised. An overview of the studies is provided in Table 1.
Table 1
Included study characteristics
Study
details/location
Inclusion
criteria
Exclusion
criteria
Number of patients;
length of follow up;
losses to follow up
Conflicts of interest
Obi et al 201530†
Patients with
COPD
NR
n = 12
None disclosed
Level II interventional
evidence
Length of follow up:
10 weeks
Losses: 3
Single centre
USA
Carlin et al 20154
Prospective level III-2
interventional evidence
Single centre
USA
Stable COPD
with current use
of supplemental
oxygen during
rest and exertion,
self-reported
dyspnoea-related
activity limitation,
and ability to
perform ADL
such as walking,
cleaning and
climbing stairs
Tobacco smokers,
patients with acute
respiratory
symptoms
n = 30
Length of follow up:
measurement
recorded same day as
test
Losses: 1
Non-invasive open ventilation (NIOV™) system: April 2016
Study sponsored by
Breathe Technologies,
Inc. One author serves as
a consultant to Breathe
Technologies, Inc. and
another author was an
employee of the same
company
6
Study
details/location
Porszasz et al 201331
Prospective level III-2
interventional evidence
Single centre
Inclusion
criteria
Patients with
spirometric
COPD criteria
Exclusion
criteria
Women and
obese patients
Number of patients;
length of follow up;
losses to follow up
Conflicts of interest
n = 15 (all male)
Study sponsored by
Breathe Technologies,
Inc. All but one author
reported conflicts of
interest involving Breathe
Technologies, Inc.
including consulting fees,
support for travel, and
fees for writing or
reviewing the manuscript
or data analysis. One
author is employed by
Breathe Technologies,
Inc.
Length of follow up:
Not reported*
Losses: 0
USA
ADL: activities of daily living; COPD: chronic obstructive pulmonary disease; NR: not reported
*Study involved four visits in total. Interval between visits was 2—7 days in 70% of cases and 2—14 days in 82% of cases
†Presented in the form of a meeting abstract
Obi et al 201530
A randomised controlled trial published in the form of a meeting abstract reported on the
effects of the NIOV system on dyspnoea severity and exercise capacity in 12 COPD patients
undergoing standard pulmonary rehabilitation (level II intervention evidence). Patients were
randomly assigned to receive oxygen through either a nasal cannula or the NIOV device.
Outcomes assessed at the beginning and end of the 10-week pulmonary rehabilitation
program included the mMRC dyspnoea score, CAT score and 6-minute walk test distance.
Data were collected from nine patients in total (five from the nasal cannula treatment group
and four from the NIOV treatment group). Reasons were not provided for the three patients
lost to follow up.
Effectiveness
Results for effectiveness varied (Table 2). The average dyspnoea score decreased in the
NIOV treatment group by week 10, meaning that patients perceived themselves to be less
breathless. In contrast, the average dyspnoea score increased in the nasal cannula
treatment group, meaning that patients perceived themselves to be more breathless.
However, patients in the cannula group had a greater average improvement in 6-minute
walk test distance by week 10 than those in the NIOV treatment group. Both treatment
groups showed an improvement in average CAT scores by week 10, meaning that patients
felt there was a reduction in the impact of COPD on their lives. No statistical analyses of the
data were reported.
Non-invasive open ventilation (NIOV™) system: April 2016
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Table 2
Change in mMRC score, CAT score and 6-MWT distance during NIOV and nasal cannula
treatments30
Test
Week 1
(NIOV)
Week 1
(Nasal cannula)
Week 10
(NIOV)
Week 10
(Nasal Cannula)
Mean mMRC dyspnoea score
2.12
2.2
1.75
3.0
Mean CAT score (average)
26.5
21.4
21.3
18.8
250 feet
362 feet
Mean 6-MWT distance
6-MWT: 6-minute walk test; CAT: Chronic Obstructive Pulmonary Disease Assessment Test; mMRC: modified Medical Research Council
Safety
Not reported.
Carlin et al 20154
In this prospective, non-randomised comparative study, Carlin et al 2015 compared the
effect of the NIOV system with standard oxygen therapy in 30 patients with stable, oxygendependent COPD (level III-2 Intervention evidence).It is not stated whether patient
enrolment was consecutive. The study involved a crossover design whereby patients first
performed a self-selected activity of daily living (ADL), such as walking, stair climbing or
cleaning, for as long as tolerable using standard oxygen therapy. Following a rest of at least
15 minutes, the patients then performed the same ADL for as long as tolerable using the
NIOV system. For the standard oxygen treatment, the patients used their existing nasal
cannula at the prescribed flow rates for rest and exertion. For the NIOV treatment, patients
were familiarised with the system on the day of testing. This involved a fitting with the NIOV
nasal pillow interface and optimising the ventilator’s volume, inspiratory time and trigger
sensitivity settings for both rest and activity. Approximately five minutes before each test,
baseline values were collected for heart rate, respiratory rate, dyspnoea, fatigue, discomfort
and the amount of oxygenated haemoglobin in the blood (SpO2).
The primary outcome measured in the study was ADL endurance time. Secondary outcomes
included SpO2 and dyspnoea (measured using the Borg Dyspnoea Scale), fatigue and
discomfort scores. A per-protocol approach, defined as having at least minimal use of both
study treatments, was used for data analyses. Of the 30 enrolled patients, 29 successfully
completed both study treatment arms. Data from the patient who dropped out were
excluded from the efficacy, but included in the safety analyses.
Effectiveness
Significantly better responses for all outcomes were reported in the NIOV treatment
compared with standard oxygen therapy treatment (Table 3).
Non-invasive open ventilation (NIOV™) system: April 2016
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Table 3
Summary of results for the crossover comparison of standard oxygen therapy (first
treatment) and the NIOV system (second treatment after at least 15 minute rest)4
Variable
Standard oxygen
therapy
NIOV system
p value
Mean ADL endurance in minutes ± SD
7.2 ± 5.21
13.4 ± 7.50
p<0.0001
Mean SpO2 ± SD*
90.7% ± 4.87
94.8% ± 1.99
p<0.0001
Mean Borg score [95% CI]†
3.0 [2.80, 4.07]
1.0 [1.16, 2.40]
p<0.0001
Mean fatigue score [95% CI]
5.0 [2.56, 5.15]
2.0 [2.03, 3.77]
p=0.0005
Mean discomfort score [95% CI]
4.5 [3.17, 4.86]
2.0 [1.96, 3.63]
p=0.01
CI: confidence interval; SD: standard deviation
*Estimate of arterial oxygen saturation (amount of oxygenated haemoglobin in the blood)
†Borg Dyspnoea Scale measures perceived exertion; lower scores indicate less breathing difficulty
A meeting abstract32 reported interim results for 12 patients (mean age 72.3 years) from the
Carlin et al 20154 study. Mean time from diagnosis to initiation of the NIOV system
treatment was 16.8 months. Both modified Medical Research Council (mMRC) dyspnoea
scores and COPD Assessment Test (CAT) scores improved in patients using the NIOV system
for an average of 11 months. The mean mMRC dyspnoea score reduced from 3.3 (range 2-4)
to 1.7 (range 0-4), whilst the mean CAT score reduced from 27.2 (range 10-37) to 14.5
(range 4-27).
Safety
A single adverse event was observed in one patient who was unable to use the NIOV system
treatment owing to nasal congestion and rhinorrhoea. 4 The patient did not require
treatment, and the event was deemed unrelated to the study interventions.
Porszasz et al 201331
In this prospective, non-randomised comparative study Porszasz et al 201331 investigated
the effects of the NIOV system on exercise tolerance in 15 men with COPD (level III-2
intervention evidence). The study did not explain why only men were included, nor whether
they were consecutively enrolled.
The experiment involved four visits. On the first visit, patients performed incremental
exercise testing (5 to 10 minutes in duration) and then, following 1.5 hours’ rest, performed
constant work rate (CWR) endurance testing at 80 per cent peak work rate. Exercise was
conducted with patients breathing air through a mouthpiece. All tests were performed to
each patient’s limit of tolerance. Ventilation and gas exchange were measured breath by
breath. On visit two, patients exercised at the CWR determined at the first visit, whilst
subjected to the following breathing treatments: unassisted breathing of ambient air;
breathing using the NIOV system driven by compressed air; and breathing using the NIOV
system driven by compressed oxygen. On visit three, the tests conducted on the second visit
were repeated. On visit four, patients performed CWR tests whilst subjected to the
Non-invasive open ventilation (NIOV™) system: April 2016
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following breathing treatments: breathing oxygen via a standard nasal cannula; or breathing
using the NIOV system plus oxygen. The interval between visits was two to seven days in 70
per cent of cases and two to 14 days in 82 per cent of cases.
Outcomes assessed included exercise duration, surface inspiratory muscle
electromyography (EMG) (measures the activity of the rib muscles and diaphragm), SpO2,
transcutaneous partial pressure of carbon dioxide in the blood (TcPCO2) and Borg dyspnoea
score. Each outcome, excluding exercise duration, was compared at isotime (the shortest
CWR test during visits 1 to 4) and peak exercise. Results for the breathing of oxygen through
a nasal cannula were unavailable for one patient, with no reason provided for this loss to
follow up. Data for the remaining treatments are based on the results from all 15 patients.
Effectiveness
Patients using the NIOV system driven by compressed oxygen had significantly better
responses for rib muscle EMG (reduced activation of rib muscles), heart rate (reduced) and
SpO2 (increased), compared with breathing ambient air unassisted, breathing using the NIOV
system driven by compressed air and breathing oxygen via a nasal cannula (p<0.05; Table 4).
Significant reductions were also recorded in breathing frequency and Borg Dyspnoea scores
in patients using the NIOV system driven by compressed oxygen, compared with patients
using the NIOV system driven by compressed air and those breathing ambient air unassisted
(p<0.05), but not compared with patients breathing oxygen via a cannula (p>0.05; Table 4).
Table 4
Mean physiologic responses to constant work rate exercise at isotime31
Variable
CWR
(breathing air
through a
mouthpiece)
(V1)
Unassisted
ambient air
breathing (V2
and V3)
NIOV + air
breathing (V2
and V3)
Oxygen by
cannula
breathing (V4)
NIOV + oxygen
breathing (V2,
V3 and V4)
Scalene EMG, µV/s ± SD
n/a
9.3 ± 6.3
8.1 ± 6.5
5.7 ± 6.5*†
3.1 ± 2.6*†‡
Intercostal EMG, µV/s ± SD
n/a
3.5 ± 2.7
2.9 ± 2.1*
2.6 ± 2.5*
1.7 ± 2.1*†‡
Diaphragmatic EMG, µV/s ± SD
n/a
4.8 ± 2.2
4.5 ±1.8
3.2 ±1.8*†
2.5 ±1.5*†‡
Breathing frequency,
breaths/minute ± SD
31.1 ± 10.4
29.6 ± 8.1
27.5 ± 7.1
23.5 ± 6.5*§
23.8 ± 7.7*§
Heart rate, beats/minute ± SD
121 ± 16
112 ± 14§
114 ± 15 §
110 ± 13 §
105 ± 12*†‡§
SpO2, % ± SD
86.9 ± 2.9
88.2 ± 2.2
87.9 ± 3.8
92.7 ± 3.9*†§
98.5 ± 1.0*†‡§
TcPCO2, mmHg ± SD
45.9 ± 6.8
45.4 ± 7.4
43.4 ± 6.4
42.7 ± 5.6
45.2 ± 6.5
Borg CR10 score ± SD
4.7 ± 2.8
4.6 ± 2.0
3.3 ± 1.8*§
2.5 ± 1.7*§
1.8 ± 1.3*†§
Borg CR10 score: dyspnoea rating on a 10-point scale; CWR: constant work rate test performed at visit 1; EMG: electromyography (reported
relative to resting level. For studies performed on more than one visit, responses were averaged); n/a: not applicable; NIOV: non-invasive
open ventilation; SD: standard deviation; SpO2: arterial oxygen saturation measured by transcutaneous oximetry; TcPCO2: transcutaneous
partial pressure of carbon dioxide in the blood; V1–V4: data from visit 1 through to visit 4
*p<0.05 (vs. air unassisted); † p<0.05 (vs. NIOV plus air); ‡ p<0.05 (vs. oxygen via cannula); § p<0.05 (vs. CWR)
Non-invasive open ventilation (NIOV™) system: April 2016
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For physiologic responses to CWR at limit of tolerance, patients using the NIOV system
driven by compressed oxygen had significantly better exercise endurance than with any
other treatments (p<0.05; Table 5). Compared with using oxygen breathed through a nasal
cannula, exercise endurance using the NIOV system driven by compressed oxygen was
improved by an average of 6.1 minutes (p<0.001). In addition, patients using the NIOV
system driven by compressed oxygen had significantly better SpO2 than all other treatments
(p<0.05). No significant differences were seen among any of the treatments with respect to
heart rate, Borg Dyspnoea Scale score or TcPCO2 (p>0.05; Table 5).
Table 5
Mean physiologic responses to constant work rate exercise at limit of tolerance 31
CWR (breathing
air through a
mouthpiece) (V1)
Unassisted
ambient air
breathing
(V2 and V3)
NIOV + air
breathing
(V2 and V3)
Oxygen by
cannula
breathing (V4)
NIOV + oxygen
breathing
(V2, V3 and V4)
n/a
9.7 ± 6.8
9.5 ± 7.0
7.7 ± 6.5
6.8 ± 5.1*†
n/a
3.8 ± 3.1
3.3 ± 2.3*
3.7 ± 3.3
2.8 ± 2.3*
n/a
5.1 ± 2.3
5.3 ± 2.2
4.1 ± 2.3*†
4.0 ± 2.2*†
33.8 ± 9.8
28.8 ± 7.8‡
26.7 ± 7.3‡
27.1 ± 7.8‡
26.6 ± 6.7‡
125 ± 17
118 ± 14‡
120 ± 13‡
120 ± 17
119 ± 13
SpO2, % ± SD
85.1 ± 3.4
86.0 ± 2.9
85.9 ± 4.1
91.2 ± 4.2*†‡
97.4 ± 1.8*†‡§
TcPCO2, mmHg ± SD
47.3 ± 6.7
46.3 ± 7.6
44.8 ± 7.0
43.5 ± 4.5
47.5 ± 7.4
Borg CR10 score ±
SD
6.7 ± 2.3
6.6 ± 2.5
6.3 ± 2.5
6.3 ± 3.6
6.1 ± 2.9
Tlim, minutes ± SD
5.1 ± 1.1
5.6 ± 1.9
6.3 ± 4.1
11.4 ± 6.8*†‡
17.6 ± 5.7*†‡§
Scalene EMG,
µV/s ± SD
Intercostal EMG,
µV/s ± SD
Diaphragmatic EMG,
µV/s ± SD
Breathing frequency,
breaths/minute ± SD
Heart rate,
beats/minute ± SD
Borg CR10 score: dyspnoea rating on a 10-point scale; CWR: constant work rate test performed at visit 1; EMG: electromyography (reported
relative to resting level. For studies performed on more than one visit, responses are averaged); n/a: not applicable; NIOV: non-invasive open
ventilation; SD: standard deviation; SpO2: arterial oxygen saturation measured by transcutaneous oximetry;TcPCO2: transcutaneous partial
pressure of carbon dioxide in the blood; T lim: edurance time; V1–V4: data from visit 1 through to visit 4
*p<0.05 (vs. air unencumbered)
† p<0.05 (vs. NIOV plus air)
‡ p<0.05 (vs. CWR)
§ p<0.05 (vs. oxygen via cannula)
Safety
Safety data were not reported.
Economic evaluation
No economic evaluation studies on the NIOV system were identified.
Ongoing research
No ongoing trials for the NIOV system were identified from a search of ClinicalTrials.gov and
the Australian and New Zealand Clinical Trials Registry.
Non-invasive open ventilation (NIOV™) system: April 2016
11
Other issues
Two of the three studies included in this Brief (Porszasz et al 201331 and Carlin et al 20154)
were funded by Breathe Technologies Inc. Furthermore, authors of three of the included
studies (Porszasz et al 201331, Carlin et al 20154 and Carlin et al 201432) declared conflicts of
interest involving Breathe Technologies, Inc. (Table 1).
Number of studies included
All evidence included for assessment in this Technology Brief has been assessed according
to the revised NHMRC levels of evidence. A document summarising these levels may be
accessed via the HealthPACT web site.
Total number of studies: 3
Total number of Level II studies: 1
Total number of Level III-2 studies: 2
Search criteria to be used (MeSH terms)
Noninvasive open ventilation OR NIOV OR open ventilation system OR open ventilator
system or open ventilation device OR open ventilator device
AND
COPD OR chronic obstructive pulmonary disease OR ‘pulmonary disease, chronic
obstructive’ (MeSH)
Date searched
26/10/2015
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