CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

Phase 3

Completed

• Conditions: Severe Acute Cardiogenic Pulmonary Edema

• Registration Number: NCT00213681
• Lead Sponsor: University Hospital, Rouen

Brief Summary

To evaluate whether bilevel positive airway pressure more rapidly improves ventilation than continuous positive airway pressure (CPAP) in patients with acute pulmonary edema. CPAP is delivered via a simple device connected to oxygen.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2005-03
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-21
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• age > 16 yrs, acute onset of severe respiratory distress, bilateral rales and typical findings of congestion on chest radiograph
• breathing frequency of > 30/min, SpO2 >90%, use of accessory respiratory muscles

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in PaCO2 at the end of ventilation

Secondary Outcome Measures

Name	Time	Method
Blood gases, vital signs
Time to transfer to medical ward
Time to hospital discharge
Endotracheal intubation, myocardial infarction and mortality during the first 24 hours
Duration of the ventilation
Easiness to use was evaluated by nurses
Patients operational tolerance
Complications of each ventilation mode