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

Primary Purpose

Pneumonia, Community-Acquired Infections, Respiratory Insufficiency

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Castar Starmed (CPAP) delivered by a helmet
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring CPAP, community-acquired pneumonia, acute respiratory failure, hypoxemia, Continuous Positive Airway Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

CPAP delivered by a helmet

O2 administration via a conventional Venturi mask

Outcomes

Primary Outcome Measures

Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315

Secondary Outcome Measures

PaO2/FiO2 Ratio Mantainance
the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement

Full Information

First Posted
January 16, 2008
Last Updated
October 26, 2009
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT00603564
Brief Title
Helmet Continuous Positive Airway Pressure Versus Oxygen Venturi in Acute Respiratory Failure in CAP: CAPOVeRSO
Acronym
CAPOVeRSO
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely interrupted because patients randomized to CPAP reached the endpoint quicker than anticipated in the protocol
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Milan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Community-Acquired Infections, Respiratory Insufficiency, Acute Lung Injury
Keywords
CPAP, community-acquired pneumonia, acute respiratory failure, hypoxemia, Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
CPAP delivered by a helmet
Arm Title
2
Arm Type
No Intervention
Arm Description
O2 administration via a conventional Venturi mask
Intervention Type
Procedure
Intervention Name(s)
Castar Starmed (CPAP) delivered by a helmet
Other Intervention Name(s)
Castar Starmed CP209/2
Intervention Description
Continuous Positive Airway Pressure delivered by a helmet with PEEP valve of 10 cmH2O and FiO2 0.5
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
PaO2/FiO2 Ratio Mantainance
Description
the number of subjects who could maintain, once reached, a PaO2/FiO2 ratio ≥315 at 1 and 24 hours after the qualifying measurement
Time Frame
1, 6, 12, 24 and 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
roberto cosentini, MD
Organizational Affiliation
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Official's Role
Study Chair
Facility Information:
Facility Name
Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena
City
Milan
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
2403506
Citation
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.
Results Reference
background
PubMed Identifier
11008980
Citation
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.
Results Reference
background
PubMed Identifier
20154071
Citation
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.
Results Reference
derived

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

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