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Impact of Non-intentional Leaks on Noninvasive Ventilation

Impact of Non-intentional Leaks on Breathing Pattern and Work of Breathing During Non-invasive Ventilation: Study in Awakened Healthy Subjects and Awakened Obesity Hypoventilation Syndrome(OHS)Patients and During the Sleep in OHS Patients.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00983411
Acronym
NIV-Leaks
Enrollment
20
Registered
2009-09-24
Start date
2009-09-30
Completion date
2011-04-30
Last updated
2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Positive-pressure Ventilation, Respiratory Physiological Phenomena

Keywords

non-invasive intermittent positive-pressure ventilation, work of breathing, Pulse transit time

Brief summary

The investigators hypothesized that increasing non intentional leaks could increase work of breathing and could lead to patient/non-invasive ventilation (NIV) asynchrony. The main objective is to compare ventilatory pattern (work of breathing, flow, pressure) under NIV with and without non-intentional leaks in 10 awakened healthy subjects and 10 awakened and asleep obese hypoventilation syndrome (OHS) patients. Methods: While the subjects will be under NIV, several levels of leaks will be simulated in a random order with an automatically opening valve. Breathing pattern (work of breathing,flow, pressure, thorax and abdominal movements) will be recorded by Polygraphy. Healthy subjects will be recorded only during awakened state. OHS patients will be recorded both during awake and sleep sates. Analysis: A repeated measures analysis of variance (ANOVA) will compare work of breathing according to the different levels of leaks.

Interventions

OTHERNon intentional leaks during non invasive ventilation

During NIV sessions (in awake state for both the 10 healthy and the 10 OHS subjects and during sleep only for the OHS subjects), the investigators will create several levels of non intentional leaks in a random order

Sponsors

AGIR à Dom
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* OHS patients, in stable stade, teated with nocturnal non invasive ventilation for at least three months. * Healthy subjects without known pathology

Exclusion criteria

* OHS patients: instable cardio-respiratory status and/or acute cardio-respiratory failure three month before the inclusion. Latex allergy, oesophageal varices.

Design outcomes

Primary

MeasureTime frame
Main outcome measure:Work of breathing assessed by measurement of oesophageal pressure according to the levels of non intentional leaks during non invasive ventilationOesophageal pressure will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients)

Secondary

MeasureTime frame
Secondary outcome measure: Assessments of the pulse transit time (PTT) and measurement of the oral opening (JAWSENS-NOMICS)according to the levels of non intentional leaks during non invasive ventilationPTT and oral opening will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026