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

Sponsor

AGIR à Dom (Other)

Overall Status

Completed

CT.gov ID

NCT00983411

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intermittent Positive-pressure Ventilation Respiratory Physiological Phenomena	Other: Non intentional leaks during non invasive ventilation

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Other

Time Perspective:

Prospective

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 :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laboratoire EFCR et Sommeil CHU Grenoble	Grenoble		France	38043

Sponsors and Collaborators

AGIR à Dom

Investigators

Principal Investigator: Jean Louis Pepin, Pr, Laboratoire EFCR et Sommeil, CHU Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AGIR à Dom

ClinicalTrials.gov Identifier:

NCT00983411

Other Study ID Numbers:

AGIR-02

First Posted:

Sep 24, 2009

Last Update Posted:

Feb 1, 2017

Last Verified:

Sep 1, 2009

Keywords provided by AGIR à Dom

non-invasive intermittent positive-pressure ventilation

work of breathing

Pulse transit time

Study Results

No Results Posted as of Feb 1, 2017