CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213681
First received: September 14, 2005
Last updated: June 17, 2013
Last verified: June 2013
  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:


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
Accepts Healthy Volunteers:   No
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
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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

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213681     History of Changes
Other Study ID Numbers: 2001/059/HP
Study First Received: September 14, 2005
Last Updated: June 17, 2013
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 July 23, 2014