Clinical Trial: Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Comparison of CPAP Delivered by Helmet and O2 Therapy With Venturi Mask for the Treatment of Acute Respiratory Failure in Community-acquired Pneumonia
Brief Summary: The purpose of this study is to compare the efficacy of CPAP application by a helmet and O2 administration by a Venturi mask in terms of gas exchanges improvement in patients with acute respiratory failure due to community-acquired pneumonia.
Detailed Summary:
Community-acquired pneumonia (CAP) is one of the commonest causes of hospitalised acute respiratory failure with a mortality rate up t 30%.
Continuous Positive Airway Pressure (CPAP) has ben recently proved to be effective. To date, however, no prospective randomised study has been published on the comparison between CPAP and O2 administration via a Venturi mask for the treatment of acute respiratory failure in immunocompetent patients with community-acquired pneumonia.
Therefore, the aim of this study is to compare the efficacy of CPAP delivered by a helmet and O2 administration via a Venturi mask in terms of gas exchanges improvement in early acute respiratory failure (PaO2/FiO2 between 210 and 285)due to community-acquired pneumonia.
A Steering Committee composed by the principal investigators will request an interim analysis at 20% enrolment in order to monitor the criteria for equipoise of the two treatments.
Sponsor: University of Milan
Current Primary Outcome: Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315 [ Time Frame: on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315 ]
Original Primary Outcome: time of gas exchange improvement to PaO2/FiO2 ratio > 315 [ Time Frame: period during hospital stay ]
Current Secondary Outcome: PaO2/FiO2 Ratio Mantainance [ Time Frame: 1, 6, 12, 24 and 48 hours ]
Original Secondary Outcome: number of patients who maintain PaO/FiO2 ratio above 315 for at least two consecutive blood gas determinations (1 hour and 24 hours after the achievement of the primary outcome measure, i.e.: PaO2/FiO2 > 315) [ Time Frame: 1 h and 24 h after primary outcome achievement ]
Information By: University of Milan
Dates:
Date Received: January 16, 2008
Date Started: January 2006
Date Completion:
Last Updated: October 26, 2009
Last Verified: October 2009
