Target Volume in Noninvasive Positive Pressure Ventilation (CIBLE)

March 13, 2014 updated by: AGIR à Dom

Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial

Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38900
        • Sleep Laboratory, Grenoble Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with Obesity hypoventilation Syndrome (BMI≥ 30 kg/m2 and diurnal PaCO2 ≥ 45mmHg at diagnosis after exclusion of others causes of hypoventilation)
  • 18 to 75 years old
  • In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night).

Exclusion Criteria:

  • patient treated with additional long term Oxygen therapy
  • Patient previously treated by AVAPS mode or IVAPS mode

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AVAPS
AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night
Device: IVAPS
IVAPS mode (RESMED Stelar 150) during 1 night
Active Comparator: IVAPS
IVAPS mode(STELAR 150-RESMED)1 night
Device: AVAPS
AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)
Time Frame: 1 night
transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.
1 night

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean transcutaneous CO2 pressure during REM Sleep
Time Frame: 1 Night
1 Night
Mean nocturnal SpO2
Time Frame: 1 night
1 night
Awake arterial PaCO2 after 1 hour of NIPPV withdrawal
Time Frame: After 1 night
After 1 night
Micro-arousals/hour of sleep
Time Frame: 1 night
1 night
Sleep Quality assess by Visual analogic scale (100mm)
Time Frame: 1 night
1 night
Respiratory residual events detected by NIPPV built-in softwares
Time Frame: 1 Night
1 Night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGIR à Dom

Collaborators

ResMed

Investigators

  • Principal Investigator: Jean Louis Pepin, MD PHD, CHU Grenoble France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-AGIR-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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