Extracorporeal Membrane OxygenationNCT02809703
Quality of Life Following ECMO
An observational study of Extracorporeal Membrane Oxygenation and Quality of Life, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Quality of Life
- What is being tested?
- Survey Questions
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 18 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent VV or VA ECMO at Duke.
Who may be able to join
- VA or VV ECMO performed during retrospective study period
Who cannot join
- Pediatric
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
Official title: Assessment of the Long Term Quality of Life Following Veno-venous and Veno-arterial Extracorporeal Membrane Oxygenation (ECMO)
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.
- Being tested
- Survey Questions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey QuestionsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life as Assessed by the WHOQOL-BREF.
Measured: 6 months to 5 years post ECMO procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start28 Aug 2017
- Primary completionJun 2018 (estimated)
- Study completion18 Jul 2018
Why it stopped: PI departed study site. Study closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809703
- Sponsor's protocol ID
- Pro00070210
- Status last verified
- Nov 2019
- First submitted
- 20 Jun 2016
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Long Term Quality of Life Following Veno-venous and Veno-arterial Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT02809703
- Acronym / sponsor ID
- Pro00070210
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI departed study site. Study closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent VV or VA ECMO at Duke.
Key inclusion criteria (1 listed)
- VA or VV ECMO performed during retrospective study period
Key exclusion criteria (1 listed)
- Pediatric
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey QuestionsSubjects will receive surveys via direct mail. They will be given the opportunity to opt in to receive a phone call regarding quality of life. | Other | – |
Primary outcome
Quality of Life as Assessed by the WHOQOL-BREF.
Time frame: 6 months to 5 years post ECMO procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation and Quality of Life, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life as Assessed by the WHOQOL-BREF. (time frame: 6 months to 5 years post ECMO procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.