Impact of Non-intentional Leaks on Noninvasive Ventilation (NIV-Leaks)
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|ClinicalTrials.gov Identifier: NCT00983411|
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : February 1, 2017
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.
|Condition or disease||Intervention/treatment|
|Intermittent Positive-pressure Ventilation Respiratory Physiological Phenomena||Other: Non intentional leaks during non invasive ventilation|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|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 Start Date :||September 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||April 2011|
Healthy and OHS subjects
10 healthy subjects: 20 to 60 years old 10 patients with Obesity hypoventilation syndrome: 20 to 70 years old treated with nocturnal non invasive ventilation for at least three months.
Other: Non 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
- 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) ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983411
|Laboratoire EFCR et Sommeil CHU Grenoble|
|Grenoble, France, 38043|
|Principal Investigator:||Jean Louis Pepin, Pr||Laboratoire EFCR et Sommeil, CHU Grenoble|