Severe Acute Cardiogenic Pulmonary Edema Clinical Trial
Official title:
CPAP Boussignac Versus Bilevel Pressure Support Ventilation in Severe Acute Cardiogenic Pulmonary Edema
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | March 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Rouen |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in PaCO2 at the end of ventilation | |||
| Secondary | Endotracheal intubation, myocardial infarction and mortality during the first 24 hours | |||
| Secondary | Duration of the ventilation | |||
| Secondary | Blood gases, vital signs | |||
| Secondary | Time to transfer to medical ward | |||
| Secondary | Time to hospital discharge | |||
| Secondary | Easiness to use was evaluated by nurses | |||
| Secondary | Patients operational tolerance | |||
| Secondary | Complications of each ventilation mode |