Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-09-30

Brief Summary

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In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency while delivering the correct level of ventilation each user requires, whatever their body position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the initial titration of therapy, while providing long term comfort and assuring therapy compliance. However, studies on the physiologic and clinical effects have not yet been performed. The aim of our singled-blind randomised multicentre controlled trial is to prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange, symptoms, body composition, level of physical activity and health-related quality of life in OHS patients.

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Detailed Description

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Efficacy on sleep quality, symptoms, physical activity and quality of life

Conditions

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Obesity Hypoventilation Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BiPAP - A40

BiPAP with AVAPS AE mode

Group Type EXPERIMENTAL

BiPAP - A40

Intervention Type DEVICE

Patients receiving BiPAP AVAPS - AE ventilatory mode at home

BiPAP- ST

Patients receiving BiPAP- ST at home

Group Type ACTIVE_COMPARATOR

BiPAP - ST

Intervention Type DEVICE

Patients receiving BiPAP- ST mode at home.

Interventions

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BiPAP - A40

Patients receiving BiPAP AVAPS - AE ventilatory mode at home

Intervention Type DEVICE

BiPAP - ST

Patients receiving BiPAP- ST mode at home.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Man or woman, stable patient with obesity hypoventilation syndrome, naives of non invasive ventilation.
* PaCO2 ≥ 45 mmHg.
* PaO2 \< 70 mmHg
* BMI ≥ 30Kg. m2

Exclusion Criteria

* Chronic obstructive pulmonary disease
* Neuromuscular disease
* Scoliosis
* Cardiac insufficiency
* Significant psychiatric disease
* Sleep apnea syndrome with central apnea index \> 10%
* Treatment with benzodiazepines at the inclusion

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No