Target Volume in Noninvasive Positive Pressure Ventilation

Not Applicable

Completed

• Conditions: Obesity Hypoventilation Syndrome
• Interventions: Device: IVAPS; Device: AVAPS

• Registration Number: NCT01748656
• Lead Sponsor: 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

Detailed Description

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

Study Timeline

• Status Verified: 2012-12
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Study Start: 2013-01
• Primary Completion: 2013-09
• Study Completion: 2014-02
• Last Update Submitted: 2014-03-13
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AVAPS	IVAPS	AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night
IVAPS	AVAPS	IVAPS mode(STELAR 150-RESMED)1 night

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mean transcutaneous CO2 pressure during REM Sleep	1 Night
Awake arterial PaCO2 after 1 hour of NIPPV withdrawal	After 1 night
Mean nocturnal SpO2	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

Trial Locations

Locations (1)

Sleep Laboratory, Grenoble Univeristy Hospital; 🇫🇷 Grenoble, France