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

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ClinicalTrials.gov Identifier: NCT01104610
Recruitment Status : Withdrawn (Stopped by the sponsor)
First Posted : April 15, 2010
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Hypoventilation Syndrome Device: Breas Vivo 40 Not Applicable

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 : Interventional  (Clinical Trial)
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 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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 Name: 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 Name: 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 Name: Breas Vivo 40 target volume



Primary Outcome Measures :
  1. Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Evolution in dyspnea scores (BDI/TDI and Simon Score) [ Time Frame: 6 weeks ]
  2. Evolution of subjective and objective sleepness (Osler) [ Time Frame: 6 weeks ]
  3. Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test) [ Time Frame: 6 weeks ]
  4. Evolution of blood inflammation (IL6, TNFα et CRP) [ Time Frame: 6 weeks ]
  5. Evolution of insulin résistance [ Time Frame: 6 weeks ]
  6. Compliance (hours of treatment) [ Time Frame: 6 weeks ]
  7. Evolution of quality of ventilation (Leaks, asynchronism, others events) [ Time Frame: 6 weeks ]
  8. Sleep quality (PSG) between the 3 groups at 6 weeks [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104610


Locations
France
CHU
Grenoble, France
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

Responsible Party: Breas Medical S.A.R.L.
ClinicalTrials.gov Identifier: NCT01104610     History of Changes
Other Study ID Numbers: OVO-2009
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Syndrome
Obesity
Hypoventilation
Obesity Hypoventilation Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases