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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01677117
Recruitment Status : Unknown
Verified August 2012 by Ling Liu, Southeast University, China.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Information provided by (Responsible Party):
Ling Liu, Southeast University, China

Brief 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.

Condition or disease
ECMO Treatment

Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Study Start Date : August 2012
Estimated Study Completion Date : December 2012

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
severe ARDS patients

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.

Responsible Party: Ling Liu, Physician of Zhongda Hospital, Southeast University, China Identifier: NCT01677117     History of Changes
Other Study ID Numbers: ECMO treatment
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012