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CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213681
First received: September 14, 2005
Last updated: December 29, 2005
Last verified: September 2005
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CPAP Boussignac Versus Bilevel Pressure Support Ventilation in Severe Acute Cardiogenic Pulmonary Edema

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00213681     History of Changes
Other Study ID Numbers: 2001/059/HP
Study First Received: September 14, 2005
Last Updated: December 29, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 22, 2013