Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema

This study has been completed.
Sponsor:
Information provided by:
Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT00390442
First received: October 17, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cardiogenic Pulmonary Edema
Device: continuous positive airway pressure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Continuous Positive Airway Pressure as a First Line Therapy in Out-of-Hospital Management of Severe Cardiogenic Pulmonary Edema

Resource links provided by NLM:


Further study details as provided by Hopital Lariboisière:

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00390442

Locations
France
Lariboisiere University Hospital
Paris, France, 75010
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Principal Investigator: Patrick Plaisance, MD, PhD, Professor Lariboisière Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00390442     History of Changes
Other Study ID Numbers: AOM03073, P030428, ENR20040504
Study First Received: October 17, 2006
Last Updated: October 17, 2006
Health Authority: France: Delegation for Clinical Research

Keywords provided by Hopital Lariboisière:
cardiogenic pulmonary edema
non invasive ventilation
CPAP

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

ClinicalTrials.gov processed this record on September 22, 2014