MedTrace Logo

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

NCT01757444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-09-11

No results posted yet for this study

Summary

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.

Conditions

  • Obesity Hypoventilation Syndrome

Interventions

DEVICE

BiPAP - A40

Patients receiving BiPAP AVAPS - AE ventilatory mode at home

DEVICE

BiPAP - ST

Patients receiving BiPAP- ST mode at home.

Sponsors & Collaborators

  • Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

    lead OTHER

Principal Investigators

  • Jean-François MUIR, Pr · Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01757444 on ClinicalTrials.gov