Long Term Outcome of Extracorporeal Membrane Oxygenation Patients in China

• Conditions: Extracorporeal Membrane Oxygenation; Long-term Outcome
• Interventions: Other: outcome

• Registration Number: NCT03345758
• Lead Sponsor: Southeast University, China

Brief Summary

Outcomes and Long-term Quality-of-life of Patients requiring Extracorporeal Membrane Oxygenation are not known in china. A prospective study 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 1,2015 to March 1,2019 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 Start: 2017-08-01
• Study First Submitted: 2017-10-15
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-17
• 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: 80

Inclusion Criteria

• require extracorporeal membrane oxygenation

Exclusion Criteria

• irreversible disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECMO mode,outcome	outcome	ECMO mode includes VV-ECMO and VA-ECMO, outcome includes survive condition , physical and mental health, cognitive function and social adaptation

Primary Outcome Measures

Name	Time	Method
survival rate	August,1,2017-March,1,2020	survival rate at discharge

Secondary Outcome Measures

Name	Time	Method
Quality of live	August,1,2017-March,1,2020	Questionnaire：mobility，personal care (washing/dressing)，usual activities，Pain/discomfort，Anxiety/depression
Cognitive function	August,1,2017-March,1,2020	MMSE Questionnaire

Trial Locations

Locations (1)

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