Clinical Trial: Efficacy and Safety of Non-invasive Ventilation by Calibrated Leak in the Treatment of Respiratory Acidosis in ICU

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary:

VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two mechanical ventilators during non-invasive ventilation for patient suffering from respiratory acidosis.

This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV) functioning with a turbine and with vented mask (exhalation by a calibrated leak) and a dedicated ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an exhalation valve.

Patient will be randomized before the first NIV session lasting 2 hours. After a two hours wash-out, a second NIV treatment will be delivered with the other ventilator for duration of 2 hours.

Arterial blood samples will be collected at the beginning and the end of each session of NIV. A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient monitoring.


Detailed Summary:
Sponsor: University Hospital, Grenoble

Current Primary Outcome: Carbon dioxide arterial pressure (PaCO2) [ Time Frame: After 2 hours of NIV ]

Absolute decrease in carbon dioxide arterial pressure (PaCO2) after 2 hours of ventilation


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Arterial blood acidity (pH) after 2 hours of NIV [ Time Frame: after 2 hours of NIV ]
    Correction of arterial blood acidity (pH) after 2 hours of NIV
  • Transcutaneous PCO2 [ Time Frame: 6 hours ]
    Kinetic of the PaCO2 correction, monitored via transcutaneous PCO2 captor.
  • Börg dyspnea scale [ Time Frame: 6 hours ]
  • RASS score [ Time Frame: 6 hours ]
  • Nurse satisfaction survey [ Time Frame: 6 hours ]
  • Patient satisfaction survey [ Time Frame: 6 hours ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: September 10, 2015
Date Started: April 2015
Date Completion: October 2017
Last Updated: November 16, 2016
Last Verified: November 2016