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Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema

Primary Purpose

Cardiogenic Pulmonary Edema

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
continuous positive airway pressure
Sponsored by
Hopital Lariboisière
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Pulmonary Edema focused on measuring cardiogenic pulmonary edema, non invasive ventilation, CPAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Lariboisiere University Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary endpoints :
incidence of tracheal intubation,
inotropic support,
in-hospital mortality.

Full Information

First Posted
October 17, 2006
Last Updated
October 17, 2006
Sponsor
Hopital Lariboisière
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1. Study Identification

Unique Protocol Identification Number
NCT00390442
Brief Title
Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema
Official Title
Effect of Continuous Positive Airway Pressure as a First Line Therapy in Out-of-Hospital Management of Severe Cardiogenic Pulmonary Edema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hopital Lariboisière

4. Oversight

5. Study Description

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.
Detailed Description
Cardiogenic pulmonary edema (CPE) is a frequent presenting process for acute out-of-hospital practice. Acute left heart failure may occur from a variety of processes that rapidly deteriorates to this generalized cardiopulmonary disorder. The classical treatment of out-of-hospital CPE includes supplemental oxygen, vasodilators, loop diuretics, and morphine. If not effective, or because of the associated respiratory depression, tracheal intubation and mechanical ventilation are often needed, which, by themselves are associated with a worse prognosis. Continuous positive airway pressure (CPAP) has been proposed as an alternative to mechanical ventilation in CPE. This technique not only improves alveolar recruitment and decreases the work of breathing 4 but also reduces left ventricular afterload, and both right and left ventricular preload. The overall effect of CPAP in the acute management of CPE is to improve cardio-respiratory function and sustained tissue oxygenation. Furthermore, the combination of CPAP with medical treatment in patients with CPE significantly reduces the need for intubation and improves the outcome. Unfortunately, very limited data are available on the effects of CPAP in the out-of-hospital practice. Thus, we tested the potential benefit of immediate use of CPAP alone in comparison with pharmacological therapy in treatment of CPE in the acute out-of-hospital environment. The protocol lasts 45 minutes, divided into 3 periods of 15 minutes. Patients with severe pulmonary edema are randomly assigned in 2 groups: 1/ "Early CPAP" (n=63): CPAP alone (T0-T15); CPAP + medical treatment (T15-T30); medical treatment alone (T30-T45); 2/ "Late CPAP" (n=61): medical treatment alone (T0-T15); medical treatment + CPAP (T15-T30); medical treatment alone (T30-T45). Primary endpoint : effect of early CPAP on a dyspnea clinical score and on arterial blood gases. Secondary endpoints : incidence of tracheal intubation, inotropic support, and in-hospital mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Pulmonary Edema
Keywords
cardiogenic pulmonary edema, non invasive ventilation, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure
Primary Outcome Measure Information:
Title
Primary endpoint : effect of early CPAP on a dyspnea clinical score and on arterial blood gases.
Secondary Outcome Measure Information:
Title
Secondary endpoints :
Title
incidence of tracheal intubation,
Title
inotropic support,
Title
in-hospital mortality.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Plaisance, MD, PhD, Professor
Organizational Affiliation
Lariboisière Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lariboisiere University Hospital
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

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Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema

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