Impact of Non-intentional Leaks on Noninvasive Ventilation

Respiratory Physiological Phenomena Clinical Trial

— NIV-Leaks  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983411
• Other study ID #: AGIR-02
• Status: Completed
• Phase: N/A
• First received: September 23, 2009
• Last updated: January 31, 2017
• Start date: September 2009
• Est. completion date: April 2011

Study information

• Verified date: September 2009
• Source: AGIR à Dom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Laboratoire EFCR et Sommeil CHU Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)