Clinical trial NCT00000562: Extracorporeal Support for Respiratory Insufficiency (ECMO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Respiratory Failure
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Irvine
name: Robert Bartlett
affiliation: Brigham and Women's Hospital
name: Philip Drinker
affiliation: University of Pennsylvania
name: L. Edmunds
affiliation: University of Utah
name: Alan Morris
affiliation: Icahn School of Medicine at Mount Sinai
name: E. Pierce
affiliation: University of North Carolina
name: Herbert Proctor
affiliation: University of California
name: Arthur Thomas
affiliation: Massachusetts General Hospital
name: Warren Zapol
References:
citation: National Heart, Lung, and Blood Institute, Extracorporeal Support for Respiratory Insufficiency, A Collaborative Study. December 1979.
citation: Zapol WM, Snider MT, Hill JD, Fallat RJ, Bartlett RH, Edmunds LH, Morris AH, Peirce EC 2nd, Thomas AN, Proctor HJ, Drinker PA, Pratt PC, Bagniewski A, Miller RG Jr. Extracorporeal membrane oxygenation in severe acute respiratory failure. A randomized prospective study. JAMA. 1979 Nov 16;242(20):2193-6. doi: 10.1001/jama.242.20.2193.