CPAP Versus NPPV in ACPE

Phase 4

Completed

• Conditions: Pulmonary Edema

• Registration Number: NCT00446498
• Lead Sponsor: Ospedale S. Giovanni Bosco

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2002-07
• Study Completion: 2005-05
• Study First Submitted: 2007-03-12
• Study First Submitted QC: 2007-03-12
• Study First Posted: 2007-03-13
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-02
• Last Update Posted: 2007-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• rapid onset of the symptoms
• severe dyspnoea at rest
• respiratory rate > 30 breath per minute
• use of accessory respiratory muscles
• PaO2/FiO2 < 200, radiological findings of ACPE

Exclusion Criteria

• ST elevation myocardial infarction
• hemodynamic instability (systolic arterial pressure < 90 mmHg
• need for immediate endotracheal intubation (respiratory arrest, bradypnea
• inability to protect the airways, impaired sensorium (agitation or unconsciousness
• inability to clear secretions, respiratory tract infections
• chronic obstructive pulmonary disease (COPD) exacerbation, chronic respiratory failure necessitating long-term oxygen therapy
• pulmonary embolism, pneumonia, recent oesophageal-gastric surgery
• gastrointestinal bleeding
• facial deformities
• haematological malignancy or cancer with Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intubation rate

Secondary Outcome Measures

Name	Time	Method
time of recovery
hospital length of stay
mortality and improvement in gas exchange

Trial Locations

Locations (1)

Ospedale San Giovanni Bosco Medicina d'Urgenza; 🇮🇹 Torino, Italy