CIBLE: Target Volume in Noninvasive Positive Pressure Ventilation

Sponsor

AGIR à Dom (Other)

Overall Status

Completed

CT.gov ID

NCT01748656

Collaborator

ResMed (Industry)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Obesity Hypoventilation Syndrome	Device: IVAPS Device: AVAPS	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

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 :

Jan 1, 2013

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AVAPS AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night	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

Arm

Intervention/Treatment

Active Comparator: AVAPS

AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night

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

Outcome Measures

Primary Outcome Measures

Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2) [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

Mean transcutaneous CO2 pressure during REM Sleep [1 Night]
Mean nocturnal SpO2 [1 night]
Awake arterial PaCO2 after 1 hour of NIPPV withdrawal [After 1 night]
Micro-arousals/hour of sleep [1 night]
Sleep Quality assess by Visual analogic scale (100mm) [1 night]
Respiratory residual events detected by NIPPV built-in softwares [1 Night]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).