NCT00390442

Brief Summary

In cardiogenic pulmonary edema, Continuous Positive Airway Pressure (CPAP) added to medical treatment improves outcome. The present study was designed to assess the benefit of CPAP as a first line treatment of cardiogenic pulmonary edema in the out-of-hospital environment.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
Last Updated

October 19, 2006

Status Verified

October 1, 2006

First QC Date

October 17, 2006

Last Update Submit

October 17, 2006

Conditions

Cardiogenic Pulmonary Edema

Keywords

cardiogenic pulmonary edemanon invasive ventilationCPAP

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint : effect of early CPAP on a dyspnea clinical score and on arterial blood gases.

Secondary Outcomes (4)

  • Secondary endpoints :

  • incidence of tracheal intubation,

  • inotropic support,

  • in-hospital mortality.

Interventions

continuous positive airway pressureDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clinical symptoms of acute pulmonary edema such as orthopnea, diffuse crackles without evidence of pulmonary aspiration or infection, percutaneous oxygen saturation  90% despite supplemental oxygen therapy (15 L.min-1) provided by the first responders were included in the study.

You may not qualify if:

  • patients with a history of chronic obstructive pulmonary disease, asthma, severe stenotic valvular disease, or if they had cardiovascular collapse or an impaired level of consciousness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lariboisiere University Hospital

Paris, 75010, France

Location

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Patrick Plaisance, MD, PhD, Professor

    Lariboisière Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 19, 2006

Last Updated

October 19, 2006

Record last verified: 2006-10

Locations

FR(1)