Study Stopped
Stopped by the sponsor
Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome
OVO
Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2009
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJuly 13, 2017
July 1, 2017
3 years
April 14, 2010
July 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone
6 weeks
Secondary Outcomes (8)
Evolution in dyspnea scores (BDI/TDI and Simon Score)
6 weeks
Evolution of subjective and objective sleepness (Osler)
6 weeks
Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)
6 weeks
Evolution of blood inflammation (IL6, TNFα et CRP)
6 weeks
Evolution of insulin résistance
6 weeks
- +3 more secondary outcomes
Study Arms (3)
NIV-PSV without Target Volume
ACTIVE COMPARATORPressure Support Non Invasive Ventilation without Target Volume
NIV-PSV with Target Volume
ACTIVE COMPARATORNon Invasive Pressure Support Ventilation with Target Volume set
NIV-CPAP
ACTIVE COMPARATORPressure Support Ventilation in CPAP mode
Interventions
The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with COPD and VEMS/FVC \< 65%
- Patients with CHF and periodic breathing (Ejection Fraction \<40%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU
Grenoble, France
GH Pitié-Salpétrière - Service de pneumologie et réanimation
Paris, 75651, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Louis Pepin, prof
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2010
First Posted
April 15, 2010
Study Start
May 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
July 13, 2017
Record last verified: 2017-07