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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
  Purpose

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 Intervention Phase
Obesity Hypoventilation Syndrome
 Device: Breas Vivo 40
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Breas Medical S.A.R.L.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Study Start Date: May 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • 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
  • 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
  • Breas Vivo 40 target volume

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 CHU Grenoble
  More Information

No publications provided

Responsible Party: Breas Medical S.A.R.L.
ClinicalTrials.gov Identifier: NCT01104610     History of Changes
Other Study ID Numbers: OVO-2009
Study First Received: April 14, 2010
Last Updated: February 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on June 18, 2013