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

Breas Medical

Status: Withdrawn

Conditions: Obesity Hypoventilation Syndrome

Treatments: Device: Breas Vivo 40

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104610

OVO-2009

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

NIV-PSV without Target Volume

Active Comparator group

Description:

Pressure Support Non Invasive Ventilation without Target Volume

Treatment:

Device: Breas Vivo 40

NIV-PSV with Target Volume

Active Comparator group

Description:

Non Invasive Pressure Support Ventilation with Target Volume set

Treatment:

Device: Breas Vivo 40

NIV-CPAP

Active Comparator group

Description:

Pressure Support Ventilation in CPAP mode

Treatment:

Device: Breas Vivo 40