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Target Volume in Noninvasive Positive Pressure Ventilation (CIBLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01748656
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : March 14, 2014
Information provided by (Responsible Party):
AGIR à Dom

Brief Summary:
Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option

Condition or disease Intervention/treatment Phase
Obesity Hypoventilation Syndrome Device: IVAPS Device: AVAPS Not Applicable

Detailed Description:
RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial
Study Start Date : January 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Active Comparator: AVAPS
Device: IVAPS
IVAPS mode (RESMED Stelar 150) during 1 night

Active Comparator: IVAPS
IVAPS mode(STELAR 150-RESMED)1 night
Device: AVAPS
AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night

Primary Outcome Measures :
  1. Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2) [ Time Frame: 1 night ]
    transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.

Secondary Outcome Measures :
  1. Mean transcutaneous CO2 pressure during REM Sleep [ Time Frame: 1 Night ]
  2. Mean nocturnal SpO2 [ Time Frame: 1 night ]
  3. Awake arterial PaCO2 after 1 hour of NIPPV withdrawal [ Time Frame: After 1 night ]
  4. Micro-arousals/hour of sleep [ Time Frame: 1 night ]
  5. Sleep Quality assess by Visual analogic scale (100mm) [ Time Frame: 1 night ]
  6. Respiratory residual events detected by NIPPV built-in softwares [ Time Frame: 1 Night ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient with Obesity hypoventilation Syndrome (BMI≥ 30 kg/m2 and diurnal PaCO2 ≥ 45mmHg at diagnosis after exclusion of others causes of hypoventilation)
  • 18 to 75 years old
  • In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night).

Exclusion Criteria:

  • patient treated with additional long term Oxygen therapy
  • Patient previously treated by AVAPS mode or IVAPS mode

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01748656

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Sleep Laboratory, Grenoble Univeristy Hospital
Grenoble, France, 38900
Sponsors and Collaborators
AGIR à Dom
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Principal Investigator: Jean Louis Pepin, MD PHD CHU Grenoble France

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Responsible Party: AGIR à Dom Identifier: NCT01748656    
Other Study ID Numbers: 12-AGIR-02
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: December 2012
Keywords provided by AGIR à Dom:
Noninvasive ventilation
Obesity Hypoventilation Syndrome
Additional relevant MeSH terms:
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Obesity Hypoventilation Syndrome
Pathologic Processes
Nutrition Disorders
Body Weight
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases