Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

Not Applicable

Withdrawn

• Conditions: Obesity Hypoventilation Syndrome
• Interventions: Device: Breas Vivo 40

• Registration Number: NCT01104610
• Lead Sponsor: Breas Medical S.A.R.L.

Brief Summary

The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.

Detailed Description

Compare the efficacy between 3 ventilation modes (CPAP, PSV and PSV with Target Volume) on patients with obesity hypoventilation syndrome already treated with CPAP but with persistent desaturations.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients from 20 to 75 years old.
• Body mass index > 32 kg/m2
• Nocturnal oxygen desaturation 5 mn ≤ 88% under CPAP,
• PaCO2 > 5,9 kPa in diurnal, spontaneous ventilation

Exclusion Criteria

• Patients with COPD and VEMS/FVC < 65%
• Patients with CHF and periodic breathing (Ejection Fraction <40%)
• Patients with a recent respiratory decompensation in the month preceding inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIV-PSV with Target Volume	Breas Vivo 40	Non Invasive Pressure Support Ventilation with Target Volume set
NIV-CPAP	Breas Vivo 40	Pressure Support Ventilation in CPAP mode
NIV-PSV without Target Volume	Breas Vivo 40	Pressure Support Non Invasive Ventilation without Target Volume

Primary Outcome Measures

Name	Time	Method
Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone	6 weeks

Secondary Outcome Measures

Name	Time	Method
Evolution of subjective and objective sleepness (Osler)	6 weeks
Evolution of quality of ventilation (Leaks, asynchronism, others events)	6 weeks
Evolution of blood inflammation (IL6, TNFα et CRP)	6 weeks
Evolution in dyspnea scores (BDI/TDI and Simon Score)	6 weeks
Compliance (hours of treatment)	6 weeks
Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)	6 weeks
Evolution of insulin résistance	6 weeks
Sleep quality (PSG) between the 3 groups at 6 weeks	6 weeks

Trial Locations

Locations (2)

CHU; 🇫🇷 Grenoble, France

GH Pitié-Salpétrière - Service de pneumologie et réanimation; 🇫🇷 Paris cedex 13, France