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Clinical Trial Summary

To assess the intubation rate in patients affected by severe cardiogenic pulmonary edema treated with CPAP or NPPV.


Clinical Trial Description

Background Although non-invasive ventilation has shown to be an effective treatment for acute cardiogenic pulmonary oedema (ACPO), literature still lacks of multi-centre randomised prospective studies that compares CPAP with NPPV.

Aim of the study was to assess efficacy and safety of CPAP and NPPV in patients with ACPO.

Methods 80 patients with ACPO were randomly assigned to receive CPAP or NPPV (40 for each group) through a face mask.

Inclusion criteria were: severe dyspnoea, respiratory rate > 30, PaO2/FiO2 < 200, muscle fatigue.

Main end-points were endotracheal intubation, length of ventilation, hospital length of stay and mortality. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00446498
Study type Interventional
Source Ospedale S. Giovanni Bosco
Contact
Status Completed
Phase Phase 4
Start date July 2002
Completion date May 2005

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