CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00213681
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 18, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Severe Acute Cardiogenic Pulmonary Edema Device: Boussignac CPAP - bilevel ventilation support Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CPAP Boussignac Versus Bilevel Pressure Support Ventilation in Severe Acute Cardiogenic Pulmonary Edema
Study Start Date : November 2002
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Primary Outcome Measures :
  1. Improvement in PaCO2 at the end of ventilation

Secondary Outcome Measures :
  1. Endotracheal intubation, myocardial infarction and mortality during the first 24 hours
  2. Duration of the ventilation
  3. Blood gases, vital signs
  4. Time to transfer to medical ward
  5. Time to hospital discharge
  6. Easiness to use was evaluated by nurses
  7. Patients operational tolerance
  8. Complications of each ventilation mode

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00213681

Sponsors and Collaborators
University Hospital, Rouen
Principal Investigator: Fabienne MORITZ, MD University Hospital, Rouen

Responsible Party: University Hospital, Rouen Identifier: NCT00213681     History of Changes
Other Study ID Numbers: 2001/059/HP
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by University Hospital, Rouen:
Pulmonary edema, respiratory failure, pressure support ventilation, continuous positive pressure

Additional relevant MeSH terms:
Pulmonary Edema
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases