Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: 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:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00603564
First received: January 16, 2008
Last updated: October 26, 2009
Last verified: October 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PaO2/FiO2 Ratio Mantainance [ Time Frame: 1, 6, 12, 24 and 48 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
  More Information

Publications:
Additional 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
Study First Received: January 16, 2008
Results First Received: September 11, 2009
Last Updated: October 26, 2009
Health Authority: Italy: Ethics Committee

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
Community-Acquired Infections
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infection
Thoracic Injuries

ClinicalTrials.gov processed this record on August 28, 2014