Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome (OVO)

This study has suspended participant recruitment.

(Change in sponsorship: Breas is no longer the sponsor since 17JAN2012)

Sponsor:

Information provided by (Responsible Party):

Breas Medical S.A.R.L.

ClinicalTrials.gov Identifier:

NCT01104610

First received: April 14, 2010

Last updated: February 27, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 14, 2010

Last Updated Date

February 27, 2012

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01104610 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evolution in dyspnea scores (BDI/TDI and Simon Score) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Evolution of subjective and objective sleepness (Osler) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Evolution of blood inflammation (IL6, TNFα et CRP) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Evolution of insulin résistance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Compliance (hours of treatment) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Evolution of quality of ventilation (Leaks, asynchronism, others events) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Sleep quality (PSG) between the 3 groups at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Obesity Hypoventilation Syndrome

Intervention ^ICMJE

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

Other Names:

Breas Vivo 40
Breas Vivo 40 target volume

Study Arm (s)

Active Comparator: NIV-PSV without Target Volume
Pressure Support Non Invasive Ventilation without Target Volume

Intervention: Device: Breas Vivo 40
Active Comparator: NIV-PSV with Target Volume
Non Invasive Pressure Support Ventilation with Target Volume set

Intervention: Device: Breas Vivo 40
Active Comparator: NIV-CPAP
Pressure Support Ventilation in CPAP mode

Intervention: Device: Breas Vivo 40

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2012

Estimated Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01104610

Other Study ID Numbers ^ICMJE

OVO-2009

Has Data Monitoring Committee

Responsible Party

Breas Medical S.A.R.L.

Study Sponsor ^ICMJE

Breas Medical S.A.R.L.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jean-Louis Pepin, prof

CHU Grenoble

Information Provided By

Breas Medical S.A.R.L.

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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