Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO (CAPOVeRSO)
October 26, 2009 updated by: University of Milan
A Comparison of CPAP Delivered by Helmet and O2 Therapy With Venturi Mask for the Treatment of Acute Respiratory Failure in Community-acquired Pneumonia
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.
Study Overview
Status
Terminated
Intervention / Treatment
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 (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
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Milan, Italy, 20122
- Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Community-acquired pneumonia (CAP) defined as: new chest x-ray pulmonary infiltrate, fever, and respiratory symptoms
- Acute Hypoxemic Respiratory failure
- Respiratory Rate < 35 breaths/min
- PaO2/FiO2 > 200 and < 300 while breathing oxygen for at least 15 minutes via a Venturi mask with FiO2 0.5
Exclusion criteria
- Immunosuppression
- acute cardiogenic pulmonary edema
- Patients belonging to Class II-III-IV of the NYHA
- Acute coronary syndrome
- Acute Respiratory Acidosis pH < 7.35 and PaCO2 > 45 mmHg
- More than 3 acute organ failures
- Systolic Pressure < 90 mmHg under fluid resuscitation or vasopressor drug use
- Seizures
- Decreased level of consciousness (GCS <12)
- Inability to clear secretions
- Pre-defined intubation criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
CPAP delivered by a helmet
|
Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5
Other Names:
|
|
No Intervention: 2
O2 administration via a conventional Venturi mask
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
on admission and at 1, 6, 12, 24 and 48 hours until PaO2/FiO2 ratio ≥315
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PaO2/FiO2 Ratio Mantainance
Time Frame: 1, 6, 12, 24 and 48 hours
|
the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement
|
1, 6, 12, 24 and 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Roberto Cosentini, MD, Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gregg RW, Friedman BC, Williams JF, McGrath BJ, Zimmerman JE. Continuous positive airway pressure by face mask in Pneumocystis carinii pneumonia. Crit Care Med. 1990 Jan;18(1):21-4. doi: 10.1097/00003246-199001000-00006.
- Hilbert G, Gruson D, Vargas F, Valentino R, Chene G, Boiron JM, Pigneux A, Reiffers J, Gbikpi-Benissan G, Cardinaud JP. Noninvasive continuous positive airway pressure in neutropenic patients with acute respiratory failure requiring intensive care unit admission. Crit Care Med. 2000 Sep;28(9):3185-90. doi: 10.1097/00003246-200009000-00012.
- Cosentini R, Brambilla AM, Aliberti S, Bignamini A, Nava S, Maffei A, Martinotti R, Tarsia P, Monzani V, Pelosi P. Helmet continuous positive airway pressure vs oxygen therapy to improve oxygenation in community-acquired pneumonia: a randomized, controlled trial. Chest. 2010 Jul;138(1):114-20. doi: 10.1378/chest.09-2290. Epub 2010 Feb 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
January 16, 2008
First Submitted That Met QC Criteria
January 28, 2008
First Posted (Estimate)
January 29, 2008
Study Record Updates
Last Update Posted (Estimate)
December 2, 2009
Last Update Submitted That Met QC Criteria
October 26, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAPOVeRSO 01
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