Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Hypoventilation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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NIV-PSV without Target Volume

Pressure Support Non Invasive Ventilation without Target Volume

Group Type ACTIVE_COMPARATOR

Breas Vivo 40

Intervention Type DEVICE

The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume

NIV-PSV with Target Volume

Non Invasive Pressure Support Ventilation with Target Volume set

Group Type ACTIVE_COMPARATOR

Breas Vivo 40

Intervention Type DEVICE

The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume

NIV-CPAP

Pressure Support Ventilation in CPAP mode

Group Type ACTIVE_COMPARATOR

Breas Vivo 40

Intervention Type DEVICE

The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume

Interventions

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Breas Vivo 40

The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume

Intervention Type DEVICE

Other Intervention Names

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Breas Vivo 40 target volume

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No