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
Enrollment 47
Recruitment Details 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  
Arm/Group Title CPAP (Continuous Positive Airway Pressure) Venturi
Hide Arm/Group Description CPAP delivered by a helmet O2 administration via a conventional Venturi mask
Period Title: Overall Study
Started 20 [1] 27 [1]
Completed 20 [2] 27 [2]
Not Completed 0 0
[1]
January 2006
[2]
February 2008
Arm/Group Title CPAP (Continuous Positive Airway Pressure) Venturi Total
Hide Arm/Group Description CPAP delivered by a helmet O2 administration via a conventional Venturi mask Total of all reporting groups
Overall Number of Baseline Participants 20 27 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 27 participants 47 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  40.0%
8
  29.6%
16
  34.0%
>=65 years
12
  60.0%
19
  70.4%
31
  66.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 27 participants 47 participants
65  (17) 72  (13) 69  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 27 participants 47 participants
Female
6
  30.0%
11
  40.7%
17
  36.2%
Male
14
  70.0%
16
  59.3%
30
  63.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 20 participants 27 participants 47 participants
20 27 47
1.Primary Outcome
Title Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315
Hide Description [Not Specified]
Time Frame on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP (Continuous Positive Airway Pressure) Venturi
Hide Arm/Group Description:
CPAP delivered by a helmet
O2 administration via a conventional Venturi mask
Overall Number of Participants Analyzed 20 27
Mean (Standard Deviation)
Unit of Measure: minute
405  (855) 2437  (1170)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPAP (Continuous Positive Airway Pressure), Venturi
Comments endpoint was analyzed in terms of time by comparison of mean +- SD
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title PaO2/FiO2 Ratio Mantainance
Hide Description the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement
Time Frame 1, 6, 12, 24 and 48 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP (Continuous Positive Airway Pressure) Venturi
Hide Arm/Group Description:
CPAP delivered by a helmet
O2 administration via a conventional Venturi mask
Overall Number of Participants Analyzed 20 27
Measure Type: Number
Unit of Measure: participants
19 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPAP (Continuous Positive Airway Pressure), Venturi
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000007
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CPAP (Continuous Positive Airway Pressure) Venturi
Hide Arm/Group Description CPAP delivered by a helmet O2 administration via a conventional Venturi mask
All-Cause Mortality
CPAP (Continuous Positive Airway Pressure) Venturi
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CPAP (Continuous Positive Airway Pressure) Venturi
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CPAP (Continuous Positive Airway Pressure) Venturi
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/27 (0.00%) 
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.
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
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