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

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ClinicalTrials.gov Identifier: NCT00983411
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
AGIR à Dom

September 23, 2009
September 24, 2009
February 1, 2017
September 2009
December 2010   (Final data collection date for primary outcome measure)
Main outcome measure:Work of breathing assessed by measurement of oesophageal pressure according to the levels of non intentional leaks during non invasive ventilation [ Time Frame: Oesophageal pressure will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients) ]
Same as current
Complete list of historical versions of study NCT00983411 on ClinicalTrials.gov Archive Site
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 [ Time Frame: PTT and oral opening will be assessed during all the duration of the study (2hours for the healthy subjects, overnight for the OHS patients) ]
Same as current
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Impact of Non-intentional Leaks on Noninvasive Ventilation
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.

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Observational
Observational Model: Other
Time Perspective: Prospective
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Probability Sample
10 healthy subjects recruited in professionnal area 10 patients with Obesity hypoventilation syndrome addressed to the sleep laboratory for clinical assessment
  • Intermittent Positive-pressure Ventilation
  • Respiratory Physiological Phenomena
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
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.
Intervention: Other: Non intentional leaks during non invasive ventilation
Contal O, Carnevale C, Borel JC, Sabil A, Tamisier R, Lévy P, Janssens JP, Pépin 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
April 2011
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00983411
AGIR-02
No
Not Provided
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AGIR à Dom
AGIR à Dom
Not Provided
Principal Investigator: Jean Louis Pepin, Pr Laboratoire EFCR et Sommeil, CHU Grenoble
AGIR à Dom
September 2009