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Impact of Non-intentional Leaks on Noninvasive Ventilation

NCT00983411 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2017-02-01

No results posted yet for this study

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.

Conditions

  • Intermittent Positive-pressure Ventilation
  • Respiratory Physiological Phenomena

Interventions

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

Sponsors & Collaborators

  • AGIR à Dom

    lead OTHER

Principal Investigators

  • Jean Louis Pepin, Pr · Laboratoire EFCR et Sommeil, CHU Grenoble

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-12-31
Completion
2011-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00983411 on ClinicalTrials.gov