A Comparison of CPAP Delivered by Helmet and O2 Therapy With Venturi Mask for the Treatment of Acute Respiratory Failure in Community-acquired Pneumonia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pneumonia
- Sponsor
- University of Milan
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Time to Reach an Improvement in Terms of Gas Exchange, Defined as a PaO2/FiO2 Ratio ≥315
- Status
- Terminated
- Last Updated
- 16 years ago
Overview
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.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- PaO2/FiO2 Ratio Mantainance(1, 6, 12, 24 and 48 hours)