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

This study has been terminated.
(The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603564
First Posted: January 29, 2008
Last Update Posted: December 2, 2009
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.
Information provided by:
University of Milan
  Purpose
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.

Condition Intervention
Pneumonia Community-Acquired Infections Respiratory Insufficiency Acute Lung Injury Procedure: Castar Starmed (CPAP) delivered by a helmet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • PaO2/FiO2 Ratio Mantainance [ Time Frame: 1, 6, 12, 24 and 48 hours ]

Enrollment: 47
Study Start Date: January 2006
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
CPAP delivered by a helmet
Procedure: 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 Name: Castar Starmed CP209/2
No Intervention: 2
O2 administration via a conventional Venturi mask

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603564


Locations
Italy
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
Milan, Italy, 20122
Sponsors and Collaborators
University of Milan
Investigators
Study Chair: roberto cosentini, MD Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
  More Information

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
Last Verified: October 2009

Keywords provided by University of Milan:
CPAP
community-acquired pneumonia
acute respiratory failure
hypoxemia
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Pneumonia
Respiratory Insufficiency
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Pulmonary Valve Insufficiency
Community-Acquired Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Thoracic Injuries
Wounds and Injuries
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Infection