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OVO: Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

Sponsor
Breas Medical S.A.R.L. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01104610
Collaborator
(none)
0
Enrollment
2
Locations
3
Arms
36
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Breas Vivo 40
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: NIV-PSV without Target Volume

Pressure Support Non Invasive Ventilation without Target Volume

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 target volume

    		•
    Active Comparator: NIV-PSV with Target Volume

    Non Invasive Pressure Support Ventilation with Target Volume set

    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 target volume

    		•
    Active Comparator: NIV-CPAP

    Pressure Support Ventilation in CPAP mode

    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 target volume

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone [6 weeks]

    Secondary Outcome Measures

    1. Evolution in dyspnea scores (BDI/TDI and Simon Score) [6 weeks]

    2. Evolution of subjective and objective sleepness (Osler) [6 weeks]

    3. Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test) [6 weeks]

    4. Evolution of blood inflammation (IL6, TNFα et CRP) [6 weeks]

    5. Evolution of insulin résistance [6 weeks]

    6. Compliance (hours of treatment) [6 weeks]

    7. Evolution of quality of ventilation (Leaks, asynchronism, others events) [6 weeks]

    8. Sleep quality (PSG) between the 3 groups at 6 weeks [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Grenoble France
    2 GH Pitié-Salpétrière - Service de pneumologie et réanimation Paris cedex 13 France 75651

    Sponsors and Collaborators

    • Breas Medical S.A.R.L.

    Investigators

    • Principal Investigator: Jean-Louis Pepin, prof, University Hospital, Grenoble

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Breas Medical S.A.R.L.
    ClinicalTrials.gov Identifier:
    NCT01104610
    Other Study ID Numbers:
    • OVO-2009
    First Posted:
    Apr 15, 2010
    Last Update Posted:
    Jul 13, 2017
    Last Verified:
    Jul 1, 2017
    Additional relevant MeSH terms:
    Hypoventilation
    Obesity Hypoventilation Syndrome
    Obesity
    Syndrome

    Study Results

    No Results Posted as of Jul 13, 2017