CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema - Full Text View

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213681

Purpose

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.

Condition	Intervention	Phase
Severe Acute Cardiogenic Pulmonary Edema	Device: Boussignac CPAP - bilevel ventilation support	Phase III

MedlinePlus related topics: Edema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	CPAP Boussignac Versus Bilevel Pressure Support Ventilation in Severe Acute Cardiogenic Pulmonary Edema

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

Improvement in PaCO2 at the end of ventilation

Secondary Outcome Measures:

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

Study Start Date:	November 2002
Estimated Study Completion Date:	March 2005

Eligibility

Genders Eligible for Study:

Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213681

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

Fabienne MORITZ, MD

University Hospital, Rouen

More Information

Study ID Numbers:	2001/059/HP
Study First Received:	September 14, 2005
Last Updated:	December 29, 2005
ClinicalTrials.gov Identifier:	NCT00213681
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:

Pulmonary edema, respiratory failure, pressure support ventilation, continuous positive pressure

Study placed in the following topic categories:

Signs and Symptoms
Pulmonary Edema
Respiratory Tract Diseases
Lung Diseases
Edema

ClinicalTrials.gov processed this record on January 14, 2009