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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Southeast University, China.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ling Liu, Southeast University, China
ClinicalTrials.gov Identifier:
NCT01677117
First received: August 29, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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
ECMO Treatment

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Retrospective

Further study details as provided by Southeast University, China:

Estimated Enrollment: 25
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

severe ARDS patients

Criteria

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.

  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ling Liu, Physician of Zhongda Hospital, Southeast University, China
ClinicalTrials.gov Identifier: NCT01677117     History of Changes
Other Study ID Numbers: ECMO treatment
Study First Received: August 29, 2012
Last Updated: August 29, 2012
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014