Quality of Life Following ECMO

NCT ID: NCT02809703

Last Updated: 2019-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-28

Study Completion Date

2018-07-18

Brief Summary

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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.

Detailed Description

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Conditions

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Extracorporeal Membrane Oxygenation Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* VA or VV ECMO performed during retrospective study period

Exclusion Criteria

* Pediatric
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00070210

Identifier Type: -

Identifier Source: org_study_id

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