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Clinical Trials/NCT02809703
NCT02809703
Withdrawn
Not Applicable

Assessment of the Long Term Quality of Life Following Veno-venous and Veno-arterial Extracorporeal Membrane Oxygenation (ECMO)

Duke University1 site in 1 countryAugust 28, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Extracorporeal Membrane Oxygenation
Sponsor
Duke University
Locations
1
Primary Endpoint
Quality of Life as Assessed by the WHOQOL-BREF.
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief Summary

The objective of the study is to determine the quality of life of patients in the years following treatment with extracorporeal membrane oxygenation (ECMO). The study population will include all adults treated with any configuration of ECMO at Duke University Medical Center during the period of Jan 1, 2009 and Dec 31, 2015. Patient's will be contacted by direct mail, in conjunction with a surgeon who performed their ECMO procedure or managed them while on ECMO, and asked to complete a validated survey (WHOQOL-Bref) which assesses quality of life. In addition, patients will be asked to opt-in to participate in a phone survey in which they can give a narrative about their ICU experience and answer specific questions regarding long-term comorbidities. Data will be stored in a secure online server which is HIPAA compliant and analyzed by the department of anesthesiology statistical support services. De-identified data will be shared with the WHO as specified in their usage agreement.

Registry
clinicaltrials.gov
Start Date
August 28, 2017
End Date
July 18, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • VA or VV ECMO performed during retrospective study period

Exclusion Criteria

  • Pediatric

Outcomes

Primary Outcomes

Quality of Life as Assessed by the WHOQOL-BREF.

Time Frame: 6 months to 5 years post ECMO procedure

Study Sites (1)

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