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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01104610
Other study ID # OVO-2009
Secondary ID
Status Withdrawn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
Health authority
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Status Withdrawn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

Study Design


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
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