ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by:
University of Milan

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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
No text entered.

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CPAP (Continuous Positive Airway Pressure) CPAP delivered by a helmet
Venturi O2 administration via a conventional Venturi mask
Total Total of all reporting groups

Baseline Measures
   CPAP (Continuous Positive Airway Pressure)   Venturi   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   27   47 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   8   8   16 
>=65 years   12   19   31 
Age 
[Units: Years]
Mean (Standard Deviation)
 65  (17)   72  (13)   69  (15) 
Gender 
[Units: Participants]
     
Female   6   11   17 
Male   14   16   30 
Region of Enrollment 
[Units: Participants]
     
Italy   20   27   47 


  Outcome Measures

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 ]

2.  Secondary:   PaO2/FiO2 Ratio Mantainance   [ Time Frame: 1, 6, 12, 24 and 48 hours ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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.


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 by ClinicalTrials.gov Identifier (NCT Number):

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
First Submitted: January 16, 2008
First Posted: January 29, 2008
Results First Submitted: September 11, 2009
Results First Posted: December 2, 2009
Last Update Posted: December 2, 2009