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Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO

This study has been terminated.
(The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol)
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00603564
First received: January 16, 2008
Last updated: October 26, 2009
Last verified: October 2009
History of Changes
Results First Received: September 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pneumonia
Community-Acquired Infections
Respiratory Insufficiency
Acute Lung Injury
Intervention: Procedure: Castar Starmed (CPAP) delivered by a helmet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The Steering Committee requested an interim analysis at 20% enrollment in order to monitor the criteria for actual equipoise of the two treatments. Being this unplanned, the Lan-DeMets approach was followed and a manifest superiority of the CPAP treatment was identified, with a nominal alpha exceeding the criterion for interruption set at 0.00008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CPAP (Continuous Positive Airway Pressure) CPAP delivered by a helmet
Venturi O2 administration via a conventional Venturi mask

Participant Flow:   Overall Study
    CPAP (Continuous Positive Airway Pressure)     Venturi  
STARTED     20 [1]   27 [1]
COMPLETED     20 [2]   27 [2]
NOT COMPLETED     0     0  
[1] January 2006
[2] February 2008



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   PaO2/FiO2 Ratio Mantainance   [ Time Frame: 1, 6, 12, 24 and 48 hours ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations of our study are mainly related to the early reaching of the end-point of the CPAP group. We were not able to evaluate the safety of the CPAP application and to address conclusions on its efficacy on outcomes.  


Results Point of Contact:  
Name/Title: Roberto Cosentini, MD
Organization: IRCCS Fondazione Po.Ma.Re, Milan, Italy
phone: 00390255033602
e-mail: roberto.cosentini@policlinico.mi.it


Publications:

Publications automatically indexed to this study:


Responsible Party: Roberto Cosentini, MD, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
ClinicalTrials.gov Identifier: NCT00603564     History of Changes
Other Study ID Numbers: CAPOVeRSO 01
Study First Received: January 16, 2008
Results First Received: September 11, 2009
Last Updated: October 26, 2009
Health Authority: Italy: Ethics Committee