Clinical Trial: Impact of Non-intentional Leaks on Noninvasive Ventilation

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Hypoventilatio

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.

Detailed Summary:
Sponsor: AGIR à Dom

Current Primary Outcome: Main outcome measure:Work of breathing assessed by measurement of oesophageal pressure according to the levels of non intentional leaks during non invasive ventilation [ Time Frame: Oesophageal pressure will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 [ Time Frame: PTT and oral opening will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients) ]

Original Secondary Outcome: Same as current

Information By: AGIR à Dom

Dates:
Date Received: September 23, 2009
Date Started: September 2009
Date Completion:
Last Updated: January 31, 2017
Last Verified: September 2009