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NCT03182023 Clinical Trial

Long-term Outcome of Patients Treated With Extracorporeal Membrane Oxygenation

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:
Outcomes and Long-term Quality-of-life of Patients Treated With Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03182023
Other study ID # 20170606
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2019
Est. completion date December 30, 2023

Study information
Verified date July 2022
Source Southeast University, China
Contact Ling Liu, MD
Phone 13851435472
Email liulingdoctor@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Outcomes and Long-term Quality-of-life of Patients Treated With Extracorporeal Membrane Oxygenation are not known in china.A cross-section survey will be performed to assess the long-term outcome of these patients.

Description:

Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2011 to March 1,2017 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO.

Recruitment information / eligibility
Status Recruiting
Enrollment 83
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients treated with ECMO Exclusion Criteria: - non-survivors of patients treated with ECMO,declined or lost to follow up

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Nanjing Zhong-Da Hospital, Southeast University Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Short Form-36 Health Status Questionnaire SF-36 is now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. June,2017-May,2018
Secondary EuroQol-5 Dimensions The health-related quality of patients' life was rated with use of the EQ-5D index June,2017-May,2018
Secondary the St. George's Respiratory Questionnaire(SGRQ) a fixed-format self-complete questionnaire for measuring health in chronic airflow limitation.Three component scores were calculated: symptoms, activity, and impacts (on daily life), and a total score. June,2017-May,2018
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