Target Volume in Noninvasive Positive Pressure Ventilation

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2013

Detailed Description

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

Interventions

  • Device: IVAPS
    • IVAPS mode (RESMED Stelar 150) during 1 night
  • Device: AVAPS
    • AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night

Arms, Groups and Cohorts

  • Active Comparator: AVAPS
    • AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night
  • Active Comparator: IVAPS
    • IVAPS mode(STELAR 150-RESMED)1 night

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AGIR à Dom
  • Collaborator
    • ResMed
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean Louis Pepin, MD PHD, Principal Investigator, CHU Grenoble France

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