Back to resultsTarget Volume in Noninvasive Positive Pressure Ventilation (CIBLE)
Primary Purpose
Obesity Hypoventilation Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IVAPS
AVAPS
Sponsored by
About this trial
This is an interventional treatment trial for Obesity Hypoventilation Syndrome focused on measuring Noninvasive ventilation, Obesity Hypoventilation Syndrome
Eligibility Criteria
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
Sites / Locations
- Sleep Laboratory, Grenoble Univeristy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AVAPS
IVAPS
Arm Description
AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night
IVAPS mode(STELAR 150-RESMED)1 night
Outcomes
Primary Outcome Measures
Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)
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
Mean transcutaneous CO2 pressure during REM Sleep
Mean nocturnal SpO2
Awake arterial PaCO2 after 1 hour of NIPPV withdrawal
Micro-arousals/hour of sleep
Sleep Quality assess by Visual analogic scale (100mm)
Respiratory residual events detected by NIPPV built-in softwares
Full Information
NCT ID
NCT01748656
First Posted
December 11, 2012
Last Updated
March 13, 2014
Sponsor
AGIR à Dom
Collaborators
ResMed
1. Study Identification
Unique Protocol Identification Number
NCT01748656
Brief Title
Target Volume in Noninvasive Positive Pressure Ventilation
Acronym
CIBLE
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 Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGIR à Dom
Collaborators
ResMed
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome
Keywords
Noninvasive ventilation, Obesity Hypoventilation Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AVAPS
Arm Type
Active Comparator
Arm Description
AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night
Arm Title
IVAPS
Arm Type
Active Comparator
Arm Description
IVAPS mode(STELAR 150-RESMED)1 night
Intervention Type
Device
Intervention Name(s)
IVAPS
Intervention Description
IVAPS mode (RESMED Stelar 150) during 1 night
Intervention Type
Device
Intervention Name(s)
AVAPS
Intervention Description
AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night
Primary Outcome Measure Information:
Title
Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)
Description
transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Mean transcutaneous CO2 pressure during REM Sleep
Time Frame
1 Night
Title
Mean nocturnal SpO2
Time Frame
1 night
Title
Awake arterial PaCO2 after 1 hour of NIPPV withdrawal
Time Frame
After 1 night
Title
Micro-arousals/hour of sleep
Time Frame
1 night
Title
Sleep Quality assess by Visual analogic scale (100mm)
Time Frame
1 night
Title
Respiratory residual events detected by NIPPV built-in softwares
Time Frame
1 Night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Louis Pepin, MD PHD
Organizational Affiliation
CHU Grenoble France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Laboratory, Grenoble Univeristy Hospital
City
Grenoble
ZIP/Postal Code
38900
Country
France
12. IPD Sharing Statement
Learn more about this trial
Target Volume in Noninvasive Positive Pressure Ventilation
We'll reach out to this number within 24 hrs