NCT02809703

Quality of Life Following ECMO

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extracorporeal Membrane Oxygenation
• Quality of Life

Interventions

Type	Name	Description
OTHER	Survey Questions	Subjects will receive surveys via direct mail. They will be given the opportunity to opt in to receive a phone call regarding quality of life.

Timeline

• Start date: 2017-08-28
• Primary completion: 2018-06-01
• Completion: 2018-07-18
• First posted: 2016-06-22
• Last updated: 2019-11-22

Locations

1 site across 1 country: United States