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

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

December 29, 2005

Start Date ^ICMJE

November 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Improvement in PaCO2 at the end of ventilation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00213681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

Official Title ^ICMJE

CPAP Boussignac Versus Bilevel Pressure Support Ventilation in Severe Acute Cardiogenic Pulmonary Edema

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Severe Acute Cardiogenic Pulmonary Edema

Intervention ^ICMJE

Device: Boussignac CPAP - bilevel ventilation support

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

March 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00213681

Other Study ID Numbers ^ICMJE

2001/059/HP

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital, Rouen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Fabienne MORITZ, MD

University Hospital, Rouen

Information Provided By

University Hospital, Rouen

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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