Impact of Non-intentional Leaks on Noninvasive Ventilation — NIV-Leaks  

Respiratory Physiological Phenomena Clinical Trial

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.

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Intermittent Positive-pressure Ventilation
• Obesity Hypoventilation Syndrome
• Respiratory Physiological Phenomena

• NCT number: NCT00983411
• Study type: Observational
• Source: AGIR à Dom
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Completion date: April 2011