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

Primary Purpose

Obesity Hypoventilation Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Breas Vivo 40
Sponsored by
Breas Medical S.A.R.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity Hypoventilation Syndrome

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU
  • GH Pitié-Salpétrière - Service de pneumologie et réanimation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

NIV-PSV without Target Volume

NIV-PSV with Target Volume

NIV-CPAP

Arm Description

Pressure Support Non Invasive Ventilation without Target Volume

Non Invasive Pressure Support Ventilation with Target Volume set

Pressure Support Ventilation in CPAP mode

Outcomes

Primary Outcome Measures

Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone

Secondary Outcome Measures

Evolution in dyspnea scores (BDI/TDI and Simon Score)
Evolution of subjective and objective sleepness (Osler)
Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)
Evolution of blood inflammation (IL6, TNFα et CRP)
Evolution of insulin résistance
Compliance (hours of treatment)
Evolution of quality of ventilation (Leaks, asynchronism, others events)
Sleep quality (PSG) between the 3 groups at 6 weeks

Full Information

First Posted
April 14, 2010
Last Updated
July 11, 2017
Sponsor
Breas Medical S.A.R.L.
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1. Study Identification

Unique Protocol Identification Number
NCT01104610
Brief Title
Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome
Acronym
OVO
Official Title
Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Stopped by the sponsor
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Breas Medical S.A.R.L.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIV-PSV without Target Volume
Arm Type
Active Comparator
Arm Description
Pressure Support Non Invasive Ventilation without Target Volume
Arm Title
NIV-PSV with Target Volume
Arm Type
Active Comparator
Arm Description
Non Invasive Pressure Support Ventilation with Target Volume set
Arm Title
NIV-CPAP
Arm Type
Active Comparator
Arm Description
Pressure Support Ventilation in CPAP mode
Intervention Type
Device
Intervention Name(s)
Breas Vivo 40
Other Intervention Name(s)
Breas Vivo 40 target volume
Intervention Description
The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume
Primary Outcome Measure Information:
Title
Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Evolution in dyspnea scores (BDI/TDI and Simon Score)
Time Frame
6 weeks
Title
Evolution of subjective and objective sleepness (Osler)
Time Frame
6 weeks
Title
Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)
Time Frame
6 weeks
Title
Evolution of blood inflammation (IL6, TNFα et CRP)
Time Frame
6 weeks
Title
Evolution of insulin résistance
Time Frame
6 weeks
Title
Compliance (hours of treatment)
Time Frame
6 weeks
Title
Evolution of quality of ventilation (Leaks, asynchronism, others events)
Time Frame
6 weeks
Title
Sleep quality (PSG) between the 3 groups at 6 weeks
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis Pepin, prof
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Grenoble
Country
France
Facility Name
GH Pitié-Salpétrière - Service de pneumologie et réanimation
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France

12. IPD Sharing Statement

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Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

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