Evaluation of Quality of Life and Its Influencing Factors After VA-ECMO in Refractory Cardiac Arrest Based on SF-36 Score : A Grenoble Cohort Study From 2006 Through 2018 (AQUA)

April 27, 2021 updated by: University Hospital, Grenoble
If the ExtraCorporeal Membrane Oxygenation (ECMO) improves survival in the management of refractory cardiac arrest (RCA), this technique is still an invasive technique, not devoid of complications and requiring intensive care that can have serious consequences for patients. If the studies so far show an acceptable quality of life post ECMO in refractory cardiac arrest, the study looks about the quality of life of our patients in Grenoble who survived a refractory cardiac arrest between 2006 and 2018 at the hospital university Grenoble Alps and the factors influencing this quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

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

  • France
      • Grenoble, France, 38043
        • Chu Grenoble Alpes

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

Probability Sample

Study Population

monocentric study based on clinical data and quality of life assessement,

Retrospective step :

  • Clinical data collection for live patients admissed for Refractory Cardiac Arrest with ECMO from january 2006 through december 2018,
  • Clinical data collection for live patients admissed for Refractory Cardiac Arrest without ECMO from january 2015 through december 2018,

Prospective step:

  • Quality of life assessment via telephone interview based on SF36 questionnaire performed for live patients admissed for Refractory Cardiac Arrest with ECMO from january 2006 through december 2018
  • Quality of life assessment via telephone interview based on SF36 questionnaire performed for live patients admissed for Refractory Cardiac Arrest without ECMO from january 2015 through december 2018

Description

Inclusion Criteria:

  • Adult >18 years
  • Admission to intensive care unit after a Refractory Cardiac Arrest
  • Hemodynamic instability after resumption of spontaneous cardiac activity.
  • Non-opposition of the patient or his relatives
  • Admission to intensive care unit From 2006 Through 2018

Exclusion Criteria:

  • ECMO for hypothermia or drug intoxication.
  • Comorbidity contraindicated the ECMO
  • Patients dead before hospital discharge

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
Live patients admitted for Refractory Cardiac Arrest with ECMO
Other: SF36 questionnaire via telephone interview
SF36 questionnaire via telephone interview
Live patients quality of life admitted for Refractory Cardiac Arrest without ECMO
Other: SF36 questionnaire via telephone interview
SF36 questionnaire via telephone interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global quality of life score
Time Frame: Through study completion, an average of 3 months
Items from the SF36 (Short Form 36) survey
Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live patients characteristics description
Time Frame: Through study completion, an average of 3 months
Demographic and clinical retrospective data collection
Through study completion, an average of 3 months
Vital status
Time Frame: Through study completion, an average of 3 months
Deed/Lived
Through study completion, an average of 3 months
Quality of life score related at live patients characteristics description
Time Frame: Through study completion, an average of 3 months
Items from the SF36 (Short Form 36) survey matched with live patients characteristics description
Through study completion, an average of 3 months
Quality of life score comparison
Time Frame: Through study completion, an average of 3 months
Items from the SF36 (Short Form 36) survey compared between the 2 groups ( RCA with /without ECMO) admitted from january 2015 and december 2018
Through study completion, an average of 3 months

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

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)

October 16, 2020

Primary Completion (ACTUAL)

January 15, 2021

Study Completion (ACTUAL)

April 27, 2021

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (ACTUAL)

October 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC20.225
  • 2020-A01859-30 (OTHER: ID RCB)

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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