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Observational Study
. 2025 Jan 2;65(1):2302010.
doi: 10.1183/13993003.02010-2023. Print 2025 Jan.

Comparison of oronasal and nasal masks in home mechanical ventilation: an observational cohort and bench study

Affiliations
Observational Study

Comparison of oronasal and nasal masks in home mechanical ventilation: an observational cohort and bench study

Emeline Fresnel et al. Eur Respir J. .

Abstract

Background: In patients with chronic respiratory failure, home non-invasive ventilation (NIV) is delivered through oronasal or nasal masks. Masks are a cornerstone for NIV success but can be associated with side-effects. However, the type, frequency and consequences of these side-effects are unknown. Here, we aimed to study the prevalence, nature and impact of mask-related adverse events in a cohort of stable patients. We then investigated differences between oronasal and nasal masks both in our cohort and in a bench study.

Methods: This was a prospective observational cohort including patients established on long-term NIV admitted for their elective review. Data regarding mask-related side-effects were assessed using a structured questionnaire. Our bench study was performed using a three-dimensional printed head connected to an artificial lung.

Results: 800 patients were included, of whom 84% had an oronasal mask. Moderate to very severe mask-related side-effects occurred in 47% of patients and severe to very severe side-effects occurred in 18% of patients. Side-effects were associated with poorer daytime arterial partial pressure of carbon dioxide (p=0.005), poorer subjective sleep quality (p=0.003) and poorer quality of life (p<0.001). Mask-related side-effects were more frequently reported with the use of oronasal masks compared to nasal masks (p=0.023). Our bench study showed that nasal masks were more stable than oronasal masks (p<0.001).

Conclusions: Mask-related side-effects are frequent and associated with poorer outcomes. Our data suggest that nasal masks may have a better tolerance profile and should be used as a first-line interface.

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Conflict of interest statement

Conflicts of interest: E. Fresnel reports support for the present study from ADIR Association, grants from ADIR Association and Adène Groupe, a leadership role as CEO of Kernel Biomedical, and is employed as a research engineer by Kernel Biomedical. C. Caillard reports support for the present study from Asten Santé and Kernel Biomedical, and support for attending meetings from Asten Santé and SOS Oxygène. M. Lebret reports grants from ADIR Association and Aden scientific fund, support for attending meetings from Air Liquide Medical Systems and Kernel Biomedical, and is a part-time employee of Air Liquide Medical Systems (medical affairs department) and part-time employee of Kernel Biomedical (research engineer). L. Razakamanantsoa reports support for attending meetings from Asten Santé and ASV Santé. A. Kerfourn reports support for the present study from ADIR Association, grants from ADIR Association and Adène Groupe, leadership role as CEO of Kernel Biomedical, and is employed as a research engineer by Kernel Biomedical. J. Dupuis is an employee of Asten Santé. J-F. Muir receives a salary from ADIR Association as President. E. Lhuillier reports support for attending meetings from Asten Santé. T. Similowski reports consultancy fees from AstraZeneca, Chiesi, KPL consulting, Lungpacer Inc. and OSO-AI, payment or honoraria for lectures, presentations, manuscript writing or educational events from Chiesi and Vitalaire, patents planned, issued or pending (WO2008006963A3, WO2012004534A1, WO2013164462A1), and stock (or stock options) with Austral Dx and Hephai. M. Patout reports grants from Fisher & Paykel, ResMed and Asten Santé, consultancy fees from Philips Respironics, Air Liquide Medical, ResMed, Asten Santé and GSK, payment or honoraria for lectures, presentations, manuscript writing or educational events from Philips Respironics, Asten Santé, ResMed, Air Liquide Medical, SOS Oxygène, Antadir, Chiesi, Jazz Pharmaceutical, Loewenstein, Fisher & Paykel, Bastide Medical, Orkyn and Elivie, support for attending meetings from Asten Santé and Vitalaire, participation on a data safety monitoring board or advisory board with ResMed, Philips Respironics and Asten Santé, stock (or stock options) with Kernel Biomedical, and receipt of equipment, materials, drugs, medical writing, gifts or other services from Philips Respironics, ResMed and Fisher & Paykel. The remaining authors have no potential conflicts of interest to disclose.

Figures

FIGURE 1
FIGURE 1
Realistic three-dimensional (3D) printed head model: a) 3D model of the skull and mandible structure (profile and front) with its pedestal, b) 3D model of the airway alone and when included in the skull, c) 3D printed head model covered with silicon skin and d) 3D printed head model fitted with an AirFit F20 size M mask (ResMed). e) Bench test setup.
FIGURE 2
FIGURE 2
Study flowchart.
FIGURE 3
FIGURE 3
Incidence of non-invasive ventilation-related side-effects according to type of side-effect and its severity. #: mask-related side-effect. PVA: patient–ventilator asynchrony.
FIGURE 4
FIGURE 4
Frequency of mask-related side-effects according to type of mask (p=0.023).
FIGURE 5
FIGURE 5
Comparison of patients with moderate to very severe mask-related side-effects to those without: a) daytime arterial partial pressure of carbon dioxide (PaCO2), b) subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (maximal score: 28), c) Severe Respiratory Insufficiency (SRI) Questionnaire (maximal score: 100) and d) daily use of non-invasive ventilation (NIV). Box-and-whisker plots present median and interquartile range (boxes) with minimum–maximum range (whiskers).
FIGURE 6
FIGURE 6
Results from the bench study: a) mean contact pressure, b) inspiratory–expiratory contact pressure differential, c) mean nasal contact pressure, d) mask movement, e) mean leaks, f) maximal inspiratory pressure delivered by the ventilator, g) patient work of breathing, h) triggering delay, i) inspiratory flow preceding trigger of the ventilator, j) inspiratory effort required to trigger the ventilator, k) tidal volume generated to the artificial lung and l) simulated patient–ventilator asynchrony (PVA). Box-and-whisker plots present median and interquartile range (boxes) with minimum–maximum range (whiskers).

Comment in

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