Clinical Trial: Target Volume in Noninvasive Positive Pressure Ventilation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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

Detailed Summary: RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).
Sponsor: AGIR à Dom

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: AGIR à Dom

Dates:
Date Received: December 11, 2012
Date Started: January 2013
Date Completion:
Last Updated: March 13, 2014
Last Verified: December 2012