Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO (CAPOVeRSO)
|ClinicalTrials.gov Identifier: NCT00603564|
Recruitment Status : Terminated (The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol)
First Posted : January 29, 2008
Results First Posted : December 2, 2009
Last Update Posted : December 2, 2009
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia Community-Acquired Infections Respiratory Insufficiency Acute Lung Injury||Procedure: Castar Starmed (CPAP) delivered by a helmet||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||July 2008|
Active Comparator: 1
CPAP delivered by a helmet
Procedure: Castar Starmed (CPAP) delivered by a helmet
Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5
Other Name: Castar Starmed CP209/2
No Intervention: 2
O2 administration via a conventional Venturi mask
- 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 ]
- PaO2/FiO2 Ratio Mantainance [ Time Frame: 1, 6, 12, 24 and 48 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603564
|Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena|
|Milan, Italy, 20122|
|Study Chair:||roberto cosentini, MD||Ospedale Maggiore Policlinico Mangiagalli e Regina Elena|