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Pressure Monitoring for Compartment Syndrome (VA-ECMO Trial)
N/A
Recruiting
Led By Babar Shafiq, MD, MSPT
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Sedated
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to end of hospitalization, which can be up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare different methods of diagnosing acute compartment syndrome (ACS) in patients on extracorporeal membrane oxygenation (ECMO). ACS is a condition where a limb, like an
Who is the study for?
This trial is for adults over 18 on VA-ECMO who are sedated. It's designed to help those at risk of acute compartment syndrome, a condition where limbs lose blood flow often due to ECMO itself.
What is being tested?
The study compares three methods for diagnosing ACS in ECMO patients: standard care alone, standard care with continuous pressure monitoring using the MY01 device, and standard care plus a traditional needle method (14-gauge slit catheter).
What are the potential side effects?
Potential side effects may include discomfort or pain from the pressure monitoring devices, possible skin infection at the insertion site, and bruising. The MY01 device might offer less invasive monitoring compared to the traditional needle method.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently under sedation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to end of hospitalization, which can be up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to end of hospitalization, which can be up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Deaths During Hospitalization
Number of Participants that Require Amputation
Number of Participants with Amputation-free survival
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: MY01 + standard of care groupExperimental Treatment2 Interventions
This arm involves insertion of the MY01 device into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures.
Group II: 14-gauge slit catheter monitor + standard of careExperimental Treatment2 Interventions
This arm involves insertion of the 14g slit catheter into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures.
Group III: Standard of CareActive Control1 Intervention
This arm involves standard of care monitoring.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,780 Total Patients Enrolled
Babar Shafiq, MD, MSPTPrincipal InvestigatorJohns Hopkins University