Clinical trial NCT00983411: Impact of Non-intentional Leaks on Noninvasive Ventilation
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intermittent Positive-pressure Ventilation
Respiratory Physiological Phenomena
Keywords: non-invasive intermittent positive-pressure ventilation
work of breathing
Pulse transit time
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
First posted: 2009-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10 healthy subjects recruited in professionnal area 10 patients with Obesity hypoventilation syndrome addressed to the sleep laboratory for clinical assessment

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Main outcome measure:Work of breathing assessed by measurement of oesophageal pressure according to the levels of non intentional leaks during non invasive ventilation
timeFrame: Oesophageal pressure will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients)
Secondary outcomes:
measure: 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 ventilation
timeFrame: PTT and oral opening will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Laboratoire EFCR et Sommeil CHU Grenoble
Study officials:
affiliation: Laboratoire EFCR et Sommeil, CHU Grenoble
name: Jean Louis Pepin, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Contal O, Carnevale C, Borel JC, Sabil A, Tamisier R, Levy P, Janssens JP, Pepin JL. Pulse transit time as a measure of respiratory effort under noninvasive ventilation. Eur Respir J. 2013 Feb;41(2):346-53. doi: 10.1183/09031936.00193911. Epub 2012 Apr 20.