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	Treatment or Intervention	Phase
Acute Respiratory Failure Lung Diseases	Procedure: extracorporeal membrane oxygenation	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  12 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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

Study chairs or principal investigators

Robert Bartlett,  University of California, Irvine   
Philip Drinker,  Brigham and Women's Hospital   
L. Edmunds,  University of Pennsylvania   
Alan Morris,  University of Utah   
E. Pierce,  Mount Sinai Medical Center   
Herbert Proctor,  University of North Carolina   
Arthur Thomas,  University of California   
Warren Zapol,  Massachusetts General Hospital   

Study ID Numbers:  200
Record last reviewed:  January 2000
Last Updated:  October 13, 2004
Record first received:  October 27, 1999
ClinicalTrials.gov Identifier:  NCT00000562
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08