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

July 11, 2017 updated by: Breas Medical S.A.R.L.

Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • CHU
      • Paris cedex 13, France, 75651
        • GH Pitié-Salpétrière - Service de pneumologie et réanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Breas Medical S.A.R.L.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (ESTIMATE)

April 15, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVO-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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