Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation Which is a Salvage Therapy Used in Patients With Severe Respiratory or Cardiac Failure Who Have Not Responded to Maximal Conventional Medical Therapy

NCT04653298 | Unknown

• 1 other identifier: 7951
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Extracorporeal Membrane Oxygenation (ECMO) is a salvage therapy used in patients with refractory cardiogenic shock. This rescue technique is associated to a high mortality rate and to many complications that can impact the quality of life of the survivors. The aim of this study is to evaluate the Health-related quality of life in adults after veino-arterial Extra-Corporeal Membrane Oxygenation. The quality of life will be evaluated thanks to several methods : the Short Form 36, the EQ 5D 5L and the return to work status. Then, the investigators will analyze by subgroup the quality of life according to the cardiogenic shock etiology and try to determine the risk factors of an altered quality of life. The investigators will also evaluate current comorbidities of the patient thanks to the Groll Index.

Conditions

Veno-arterial Extra-Corporeal Membrane Oxygenation; Health Related Quality of Life

Outcome Measures

Primary Outcomes (2)

• Evaluation of health-related quality of life after veino-arterial ECMO

  Quality of life will be evaluated by Short Form 36 ( score 0 to 100)

  The quality of life will be evaluated from 1 to 12 years after the ECMO

• Evaluation of health-related quality of life after veino-arterial ECMO

  EQ 5D 5L ( description of mobility, personal autonomy, routine activities, pain and discomfort, anxiety and depression and an analog visual scale)

  The quality of life will be evaluated from 1 to 12 years after the ECMO

Secondary Outcomes (3)

• Analysis by subgroup according to the cardiogenic shock etiology

  The quality of life will be evaluated from 1 to 12 years after the ECMO

• Research of risk factors of an altered quality of life

  The quality of life will be evaluated from 1 to 12 years after the ECMO

• Evaluation of the current comorbidities thanks to Groll index

  The quality of life will be evaluated from 1 to 12 years after the ECMO

Interventions

Evaluation of quality of life, comorbidities and return to work status OTHER

Quality of life will be evaluated thanks to several methods: Short Form 36, EQ 5D 5L and return to work status Questionnaires will be evaluated through postal and phone call at least 12 months after ECMO.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg are included in this study. Those patients are retrieved thanks to the Software ICCA.

You may qualify if:

• Adults \>18 years
• Veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg
• Affiliated to the French social security system

You may not qualify if:

• \- Patients under guardianship or with legal protection

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Interventions

Comorbidity

Intervention Hierarchy (Ancestors)

Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: December 4, 2020
• Study Start: December 21, 2020
• Primary Completion: December 21, 2020
• Study Completion: December 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

FR (1)