Monitoring leg pressure in patients on ECMO to prevent compartment syndrome
Official title: Continuous Compartment Pressure Monitoring for Compartment Syndrome in Venoarterial-Extracorporeal Membrane Oxygenation Patients - A Preliminary Feasibility Study
Run by Johns Hopkins University · NCT05830721 · Data updated 2026-11-12
This study is testing a new device that continuously checks leg pressure in patients on ECMO to see if it helps prevent serious leg problems better than regular methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 6 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | January 2, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | December 24, 2025 |
| Trial ID | NCT05830721 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are sedated and undergoing peripheral VA-ECMO.
✕Probably not a fit
Patients with pre-existing limb ischemia or severe extremity trauma prior to ECMO cannulation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on patients undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO) who are at risk for developing acute compartment syndrome (ACS) in the leg. It utilizes a novel device, the MY01 Continuous Compartment Pressure Monitor, which allows for continuous monitoring of compartment pressures, as opposed to traditional single measurements. By continuously tracking these pressures, the study aims to improve early diagnosis and timely intervention for ACS, which is critical for limb viability. The study compares the effectiveness of continuous monitoring with standard care practices in managing this complication.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of limb loss due to compartment syndrome in patients on ECMO.
How similar studies have gone: While the use of continuous pressure monitoring is a novel approach in this specific context, similar monitoring techniques have shown promise in other settings for diagnosing compartment syndrome.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults ≥18 years of age * Peripheral Venoarterial-Extracorporeal membrane oxygenation * Sedated Exclusion Criteria: * Any limb ischemia diagnosis prior to ECMO cannulation * Any severe extremity trauma that precludes insertion of device * Very poor prognosis (survival \>72 hours is unlikely), which also includes severe coagulopathy. Severely coagulopathic patients are at risk for severe hemorrhage and thus may not survive fasciotomy.
Where it's running
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The Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Babar Shafiq, MD, MSPT — Johns Hopkins University
- Study coordinator: Henry T Shu, BS
- Email: hshu5@jhmi.edu
- Phone: 2408050284
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.