Target Volume in Noninvasive Positive Pressure Ventilation

Obesity Hypoventilation Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748656
• Other study ID #: 12-AGIR-02
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: March 13, 2014
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: December 2012
• Source: AGIR à Dom
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoventilation
• Obesity Hypoventilation Syndrome

Intervention

Device:
• IVAPS
IVAPS mode (RESMED Stelar 150) during 1 night
• AVAPS
AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night

Locations

Country	Name	City	State
France	Sleep Laboratory, Grenoble Univeristy Hospital	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
AGIR à Dom	ResMed

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 night	No
Secondary	Mean transcutaneous CO2 pressure during REM Sleep		1 Night	No
Secondary	Mean nocturnal SpO2		1 night	No
Secondary	Awake arterial PaCO2 after 1 hour of NIPPV withdrawal		After 1 night	No
Secondary	Micro-arousals/hour of sleep		1 night	No
Secondary	Sleep Quality assess by Visual analogic scale (100mm)		1 night	No
Secondary	Respiratory residual events detected by NIPPV built-in softwares		1 Night	No