Impact of Non-intentional Leaks on Noninvasive Ventilation

NCT00983411 | Completed

• 1 other identifier: AGIR-02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Positive-pressure Ventilation; Respiratory Physiological Phenomena

Keywords

non-invasive intermittent positive-pressure ventilation; work of breathing; Pulse transit time

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

Non intentional leaks during non invasive ventilation OTHER

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

Healthy and OHS subjects

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• OHS patients, in stable stade, teated with nocturnal non invasive ventilation for at least three months.
• Healthy subjects without known pathology

Sponsors & Collaborators

• AGIR à Dom: lead

Study Sites (1)

Laboratoire EFCR et Sommeil CHU Grenoble

Grenoble, 38043, France

Location

Related Publications (1)

• 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.

  PMID: 22523360 DERIVED

Study Officials

• Jean Louis Pepin, Pr

  Laboratoire EFCR et Sommeil, CHU Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: February 1, 2017

Record last verified: 2009-09

Locations

FR (1)