Pneumonia Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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