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Extracorporeal Support for Respiratory Insufficiency (ECMO)

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ClinicalTrials.gov Identifier: NCT00000562
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Acute Respiratory Failure Lung Diseases Procedure: extracorporeal membrane oxygenation Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : June 1974
Study Completion Date : November 1979


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000562


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Robert Bartlett University of California, Irvine
OverallOfficial: Philip Drinker Brigham and Women's Hospital
OverallOfficial: L. Edmunds University of Pennsylvania
OverallOfficial: Alan Morris University of Utah
OverallOfficial: E. Pierce Icahn School of Medicine at Mount Sinai
OverallOfficial: Herbert Proctor University of North Carolina
OverallOfficial: Arthur Thomas University of California
OverallOfficial: Warren Zapol Massachusetts General Hospital
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000562     History of Changes
Other Study ID Numbers: 200
R01HL016154-05 ( Other Grant/Funding Number: US NIH Grant Number )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: January 2000

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