Long Term Outcome of Extracorporeal Membrane Oxygenation Patients in China (ECMO)

July 17, 2022 updated by: Ling Liu, Southeast University, China

Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Nanjing Zhong-Da Hospital
        • Principal Investigator:
          • Ling Liu, MD.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients treated with extracorporeal membrane oxygenation during March,1,2017 to March,1,2019

Description

Inclusion Criteria:

  • require extracorporeal membrane oxygenation

Exclusion Criteria:

  • irreversible disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECMO mode,outcome
ECMO mode includes VV-ECMO and VA-ECMO, outcome includes survive condition , physical and mental health, cognitive function and social adaptation
Other: outcome
telephone to patients to finish SF-36 (the MOS item short from health survey,SF-36)，EQ-5D(EuroQol-5 Dimensions,EQ-5D)， AMT-4（Abbreviated Mental Test-4,AMT-4）and MMSE（Mini-mental State Examination,MMSE） to make assessments of their physical and mental health, cognitive function and social adaptation after discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival rate
Time Frame: August,1,2017-March,1,2020
survival rate at discharge
August,1,2017-March,1,2020

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Study Director: Haibo Qiu, MD, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

October 15, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 17, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20170717

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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