Impact of Non-intentional Leaks on Noninvasive Ventilation (NIV-Leaks)

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.

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Physiological Phenomena; Intermittent Positive-pressure Ventilation
• Intervention / Treatment: Other: Non intentional leaks during non invasive ventilation

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Laboratoire EFCR et Sommeil CHU Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

10 healthy subjects recruited in professionnal area 10 patients with Obesity hypoventilation syndrome addressed to the sleep laboratory for clinical assessment

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: AGIR à Dom
• Investigators: Principal Investigator: Jean Louis Pepin, Pr, Laboratoire EFCR et Sommeil, CHU Grenoble

Publications and helpful links

General Publications

• Contal O, Carnevale C, Borel JC, Sabil A, Tamisier R, Levy P, Janssens JP, Pepin JL. Pulse transit time as a measure of respiratory effort under noninvasive ventilation. Eur Respir J. 2013 Feb;41(2):346-53. doi: 10.1183/09031936.00193911. Epub 2012 Apr 20.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: September 23, 2009
• First Submitted That Met QC Criteria: September 23, 2009
• First Posted (Estimate): September 24, 2009

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: work of breathing; non-invasive intermittent positive-pressure ventilation; Pulse transit time
• Other Study ID Numbers: AGIR-02