Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000562
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Extracorporeal Support for Respiratory Insufficiency ECMO
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate indications for the use and efficacy of extracorporeal membrane oxygenators ECMOs 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 60000 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 ECMOs 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 ECMOs 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 QueryViewReport QVR System
The report of the Task Force on Respiratory Diseases identified a clinical syndrome of acute respiratory insufficiency ARI and estimated that approximately 60000 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 ECMOs 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 ECMOs 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 QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL016154-05 | OTHER_GRANT | US NIH Grant Number | None |