Monitoring leg pressure in patients on ECMO to prevent compartment syndrome
Continuous Compartment Pressure Monitoring for Compartment Syndrome in Venoarterial-Extracorporeal Membrane Oxygenation Patients - A Preliminary Feasibility Study
NA · Johns Hopkins University · NCT05830721
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05830721 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are sedated and undergoing peripheral VA-ECMO.
Not a fit: Patients with pre-existing limb ischemia or severe extremity trauma prior to ECMO cannulation may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication, Limb Ischemia, Limb Ischemia, Critical, Compartment Syndrome, Venoarterial Extracorporeal Membrane Oxygenation, Compartment Pressure Measurement, ECMO