Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO
NCT ID: NCT00603564
Last Updated: 2009-12-02
Study Results
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View full resultsBasic Information
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TERMINATED
NA
47 participants
INTERVENTIONAL
2006-01-31
2008-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
CPAP delivered by a helmet
Castar Starmed (CPAP) delivered by a helmet
Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5
2
O2 administration via a conventional Venturi mask
No interventions assigned to this group
Interventions
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Castar Starmed (CPAP) delivered by a helmet
Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Milan
OTHER
Responsible Party
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Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Principal Investigators
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roberto cosentini, MD
Role: STUDY_CHAIR
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Locations
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Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, , Italy
Countries
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References
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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.
Other Identifiers
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CAPOVeRSO 01
Identifier Type: -
Identifier Source: org_study_id