Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01104610

Acronym

OVO

Enrollment

Registered

2010-04-15

Start date

2009-05-31

Completion date

2012-05-31

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Hypoventilation Syndrome

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.

Interventions

DEVICEBreas Vivo 40

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 in dyspnea scores (BDI/TDI and Simon Score)	6 weeks
Compliance (hours of treatment)	6 weeks
Evolution of quality of ventilation (Leaks, asynchronism, others events)	6 weeks
Sleep quality (PSG) between the 3 groups at 6 weeks	6 weeks
Evolution of insulin résistance	6 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026