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ECMO-Free Protocol for Extracorporeal Membrane Oxygenation Management
N/A
Recruiting
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.
Awards & highlights
Study Summary
This trial is testing whether a protocolized daily assessment of readiness for liberation from VV-ECMO is feasible and effective.
Who is the study for?
This trial is for adult patients currently receiving venovenous extracorporeal membrane oxygenation (VV-ECMO) in a participating hospital unit. It's not open to pregnant women, prisoners, minors under 18 years old, those on ECMO for over 24 hours, or individuals using it as a bridge to transplant.Check my eligibility
What is being tested?
The study compares two approaches: the 'ECMO-free protocol' which involves daily assessments to determine if patients can safely stop using VV-ECMO versus 'Usual Care' where there isn't a set protocol for weaning off. The goal is to see if structured assessments improve outcomes and reduce time on ECMO.See study design
What are the potential side effects?
While specific side effects are not listed here, generally reducing time on VV-ECMO may decrease risks associated with long-term use such as infections or blood clots. However, premature removal could lead to inadequate respiratory support.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
60-day ECMO-free days
Unsafe liberation from VV-ECMO
Secondary outcome measures
Duration of ECMO
Hospital-free days
ICU-free days
+3 moreOther outcome measures
Duration of the intervention period (days)
Number of and specific reasons for "missed" enrollments
Number of and the specific exclusion criteria met
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: The ECMO-free Protocol groupExperimental Treatment1 Intervention
For patients assigned to the ECMO-free protocol group, the study personnel will perform the ECMO-free protocol daily from enrollment until the first of death or ECMO decannulation; results will be recorded and shared with the treatment team. Final decisions regarding decannulation will be made by treating clinicians who are aware of the results of daily ECMO-free protocolized assessments.
Group II: The Usual Care GroupActive Control1 Intervention
For patients assigned to the usual care group, ECMO weaning and assessments of readiness for ECMO decannulation will be at the discretion of treating clinicians.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,133 Total Patients Enrolled
Jonathan D Casey, MD, MScStudy DirectorVanderbilt University Medical Center
4 Previous Clinical Trials
5,115 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest capacity of participants for this research study?
"Affirmative. Clinicaltrials.gov has the information that this clinical trial is actively seeking participants; it was initially posted on 7th September 2022 and recently updated on 24th October 2022, with a requirement of 60 patients from 2 distinct sites."
Answered by AI
What aims is this research endeavor attempting to accomplish?
"The primary goal of this clinical trial is to determine the amount of time until a patient's liberation from VV-ECMO. Secondary outcomes are measured in terms of ventilator-free days, hospital-free days and duration on ECMO between randomization and day 60. The entire study will span an average period of 2 years starting at randomisation."
Answered by AI
Does this clinical experiment have open enrollment for prospective participants?
"At the moment, this clinical trial is recruiting patients. The study was posted on September 7th 2022 and recently modified on October 24th of the same year."
Answered by AI
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