Extracorporeal Support for Respiratory Insufficiency (ECMO)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000562
First received: October 27, 1999
Last updated: November 25, 2013
Last verified: January 2000
  Purpose

To evaluate indications for the use and efficacy of extracorporeal membrane oxygenators (ECMO's) for the support of patients with potentially reversible acute respiratory failure.


Condition Intervention Phase
Acute Respiratory Failure
Lung Diseases
Procedure: extracorporeal membrane oxygenation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: June 1974
Study Completion Date: November 1979
Detailed Description:

BACKGROUND:

The report of the Task Force on Respiratory Diseases identified a clinical syndrome of acute respiratory insufficiency (ARI) and estimated that approximately 60,000 Americans die of ARI yearly. ARI was not precisely defined; indeed, the Task Force realized that pathologists do not recognize ARI. The Task Force pointed out that no diagnostic tests for early detection of ARI exist, that the incidence and prevalence of the disease are not known, and that existing therapy is supportive and nonspecific (diuretics, corticosteroids, etc.). The pathogenesis of the syndrome, the mechanism of interstitial edema, the defenses of the lung against agents causing ARI, and the ultrastructural pathology and natural history of the disease were virtually unknown. The Task Force indicated a need for Respiratory Care Centers with highly trained personnel that could reduce mortality from ARI.

This clinical trial grew out of the Task Force report. Nine participating centers defined ARI in clinical and physiological terms and agreed to a prospective randomized study for 3 years to compare treatment of severe ARI by conventional means with treatment by extracorporeal membrane oxygenators.

Animal studies have shown that ECMO's can provide one to two weeks' support for the lungs without serious blood damage, in contrast to bubble oxygenators, which allow complete pulmonary bypass for approximately 6 hours, after which severe blood damage occurs at the direct blood-gas interface. If patients with hypoxia secondary to acute reversible lung injury can be supported with ECMO's until the lung lesion heals, improvement in survival rates and avoidance of the hazards of conventional therapy may result. The trial, now completed, was conducted at nine clinical centers in the United States.

DESIGN NARRATIVE:

Randomized, non-blind, fixed sample; 90 eligible patients were randomly assigned to a group receiving extracorporeal membrane oxygenation plus conventional therapy or to a group receiving conventional therapy.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Men and women, ages 12 to 65, not stratified as to ethnic group, who had potentially reversible acute respiratory failure.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000562

Sponsors and Collaborators
Investigators
Investigator: Robert Bartlett University of California, Irvine
Investigator: Philip Drinker Brigham and Women's Hospital
Investigator: L. Edmunds University of Pennsylvania
Investigator: Alan Morris University of Utah
Investigator: E. Pierce Mount Sinai School of Medicine
Investigator: Herbert Proctor University of North Carolina
Investigator: Arthur Thomas University of California
Investigator: Warren Zapol Massachusetts General Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000562     History of Changes
Other Study ID Numbers: 200, R01HL016154-05
Study First Received: October 27, 1999
Last Updated: November 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014