Ignite Creation Date:
2024-05-05 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 9:43 AM
Study NCT ID:
NCT00603564
Status:
TERMINATED
Last Update Posted:
2009-12-02
First Post:
2008-01-16
Brief Title:
Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP CAPOVeRSO
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPOVeRSO
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 Description:
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 PaO2FiO2 between 210 and 285due 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
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 PaO2FiO2 between 210 and 285due 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None