AQUA: 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

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Completed
• CT.gov ID: NCT04601896
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 11.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory Cardiac Arrest; ExtraCorporeal Membrane Oxygenation (ECMO)	Other: SF36 questionnaire via telephone interview

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 75 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: 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
• Actual Study Start Date: Oct 16, 2020
• Actual Primary Completion Date: Jan 15, 2021
• Actual Study Completion Date: Apr 27, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Global quality of life score [Through study completion, an average of 3 months]

   Items from the SF36 (Short Form 36) survey

Secondary Outcome Measures

1. Live patients characteristics description [Through study completion, an average of 3 months]

   Demographic and clinical retrospective data collection

2. Vital status [Through study completion, an average of 3 months]

   Deed/Lived

3. Quality of life score related at live patients characteristics description [Through study completion, an average of 3 months]

   Items from the SF36 (Short Form 36) survey matched with live patients characteristics description

4. Quality of life score comparison [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Grenoble Alpes	Grenoble		France	38043

Sponsors and Collaborators

• University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT04601896
• Other Study ID Numbers: 38RC20.225; 2020-A01859-30
• First Posted: Oct 26, 2020
• Last Update Posted: Apr 30, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Grenoble: ExtraCorporeal Membrane Oxygenation (ECMO); Refractory Cardiac Arrest; Quality life assessement (SF36 QUESTIONNAIRE)
• Additional relevant MeSH terms: Heart Arrest

Study Results

No Results Posted as of Apr 30, 2021