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NCT01677117 Clinical Trial

Clinical Studies of the Effects of Extracorporeal Membrane Oxygenation for Severe ARDS Mortality

ECMO Treatment Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01677117
Other study ID # ECMO treatment
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 29, 2012
Last updated August 29, 2012
Start date August 2012
Est. completion date December 2012

Study information
Verified date August 2012
Source Southeast University, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians have more choices in the face of hypoxemia, and with the deepening understanding of ECMO, ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been recognized by the majority of medical workers. Therefore, we assume that accurately grasping the ECMO indications and standardizing the implementation of treatment can significantly improve the prognosis, shorter hospital stays, lower hospitalization costs.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date December 2012
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

(1) age 18-70 years; (2) severe respiratory dysfunction (Murry score = 3 points or clinical optimized ventilation conditions pH remains <7.2 patients); (3) PaCO2/FiO2 <100mmHg; (4) plateau pressure >30cmH2O more than 6h,duration of no more than seven days; (5) with severe respiratory dysfunction etiology reversible.

Exclusion Criteria:

(1) high levels pressure mechanical ventilation (PEEP> 15-20cmH2O and / or Pplat> 35-40cmH2O) over 7 days; (2) continued to receive high concentrations of oxygen (FiO2> 80%) is more than 7 days; (3) severe active bleeding; (4) within 24 hours of the surgery or head injury with intracranial bleeding; (5) a variety of serious irreversible state; (6) malignancy; (7) progressive pulmonary fibrosis; (8) can not surgical problems; (9) due to cardiac dysfunction leading to ARDS.

Study Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Southeast University, China