Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

Obesity Hypoventilation Syndrome Clinical Trial

— OVO  

Official title:

Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01104610
• Other study ID #: OVO-2009
• Status: Withdrawn
• Phase: N/A
• First received: April 14, 2010
• Last updated: July 11, 2017
• Start date: May 2009
• Est. completion date: May 2012

Study information

• Verified date: July 2017
• Source: Breas Medical S.A.R.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Syndrome

Intervention

Device:
• Breas Vivo 40
The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume

Locations

Country	Name	City	State
France	CHU	Grenoble
France	GH Pitié-Salpétrière - Service de pneumologie et réanimation	Paris cedex 13

Sponsors (1)

Lead Sponsor	Collaborator
Breas Medical S.A.R.L.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone		6 weeks
Secondary	Evolution in dyspnea scores (BDI/TDI and Simon Score)		6 weeks
Secondary	Evolution of subjective and objective sleepness (Osler)		6 weeks
Secondary	Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)		6 weeks
Secondary	Evolution of blood inflammation (IL6, TNFa et CRP)		6 weeks
Secondary	Evolution of insulin résistance		6 weeks
Secondary	Compliance (hours of treatment)		6 weeks
Secondary	Evolution of quality of ventilation (Leaks, asynchronism, others events)		6 weeks
Secondary	Sleep quality (PSG) between the 3 groups at 6 weeks		6 weeks