Long-term Outcome of Patients Treated With Extracorporeal Membrane Oxygenation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation; Long-term Outcome

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 Type: Observational
• Enrollment (Anticipated): 83

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Nanjing Zhong-Da Hospital, Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients treated with ECMO from January 1，2015 to March 1,2017

Description

Inclusion Criteria:

• patients treated with ECMO

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ECMO mode; ECMO mode includes Venovenous- ECMO and Venoarterial- ECMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol-5 Dimensions	The health-related quality of patients' life was rated with use of the EQ-5D index	June,2017-May,2018
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

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Director: Haibo Qiu, Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2019
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (ACTUAL): June 9, 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: outcome,ECMO,Respiratory Failure,Circulatory Failure
• Other Study ID Numbers: 20170606

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
• product manufactured in and exported from the U.S.: No