Long-term Outcome of Patients Treated With Extracorporeal Membrane Oxygenation

• Conditions: Extracorporeal Membrane Oxygenation; Long-term Outcome

• Registration Number: NCT03182023
• Lead Sponsor: Southeast University, China

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Study Start: 2019-01-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-17
• Last Update Posted: 2022-07-19
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• patients treated with ECMO

Exclusion Criteria

• non-survivors of patients treated with ECMO，declined or lost to follow up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short Form-36 Health Status Questionnaire	June,2017-May,2018	SF-36 is now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.

Secondary Outcome Measures

Name	Time	Method
EuroQol-5 Dimensions	June,2017-May,2018	The health-related quality of patients' life was rated with use of the EQ-5D index
the St. George's Respiratory Questionnaire(SGRQ)	June,2017-May,2018	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.

Trial Locations

Locations (1)

Nanjing Zhong-Da Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China