Limb ischemia in peripheral veno-arterial extracorporeal membrane oxygenation: a narrative review of incidence, prevention, monitoring, and treatment.
Eleonora Bonicolini, Gennaro Martucci, Jorik Simons...
https://pubmed.ncbi.nlm.nih.gov/31362770Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05830721
Continuous Compartment Pressure Monitoring for Compartment Syndrome in Venoarterial-Extracorporeal Membrane Oxygenation Patients - A Preliminary Feasibility Study
Led by Johns Hopkins University · Updated on 2025-12-24
6
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Acute compartment syndrome (ACS) is a serious surgical emergency that can occur in patients receiving extracorporeal membrane oxygenation (ECMO), especially veno-arterial (VA) ECMO. ACS happens when increased pressure in a muscle compartment reduces blood flow, leading to limb damage. Diagnosing ACS in ECMO patients is difficult because they are usually sedated and cannot report symptoms like pain. This study evaluates and compares three methods to diagnose ACS: the current standard of care, the new MY01 Continuous Compartment Pressure Monitor device alongside standard care, and a 14-gauge slit catheter device with standard care, aiming to improve accuracy and early detection. Participants will be randomly assigned to one of three groups. The standard care group involves physical exams every 4 hours and single pressure needle measurements if ACS is suspected. The MY01 group will have the device inserted into the leg near the ECMO tubing to continuously monitor pressures for 24 hours, with data accessible via a mobile app. The 14-gauge slit catheter group will use tubing inserted into the leg, connected to a monitor with pressure readings recorded every 4 hours for 24 hours. If ACS is diagnosed, surgery decisions will be made by the medical team. The device is removed after monitoring or upon diagnosis. During the study, participants will undergo regular physical exams and pressure monitoring according to their assigned group. Researchers will track the number of patients diagnosed with ACS, those needing amputation, deaths during hospitalization, and amputation-free survival, with follow-up lasting up to one year. Monitoring will include continuous or intermittent pressure measurements and clinical assessments. The study will help assess the effectiveness of continuous pressure monitoring devices compared to standard care in detecting ACS and potentially improving treatment timing and limb outcomes.
CONDITIONS
Brief Title
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Receiving peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO)
- Sedated during ECMO treatment
You will not qualify if you...
- Any limb ischemia diagnosis before ECMO cannulation
- Severe extremity trauma preventing device insertion
- Very poor prognosis with expected survival less than 72 hours, including severe coagulopathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants must be adults receiving peripheral VA-ECMO and sedated during treatment, without prior limb ischemia or severe trauma preventing device insertion.
Device Implementation
Duration - Up to 24 hours
Participants have a device inserted into the leg on the same side as the ECMO tubing to continuously monitor compartment pressures. This occurs within 6 hours of ECMO start. Monitoring lasts for 24 hours, after which the device is removed or earlier if compartment syndrome is diagnosed.
1 insertion visit and continuous monitoring for 24 hours
Standard of Care Monitoring
Duration - 24 hours
Participants receive physical exams every 4 hours for the first 24 hours to monitor for signs of compartment syndrome. If suspicion arises, an orthopedic surgeon evaluates and may perform a single pressure measurement. Monitoring stops if diagnosis is made.
Physical exams every 4 hours during 24-hour monitoring
Follow-up
Duration - Up to 1 year
Participants are followed up for up to 1 year during their hospitalization to track outcomes such as diagnosis of compartment syndrome, amputations, and survival.
Follow-up visits and assessments as part of hospitalization care
Trial Site Locations
Total: 1 location
1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
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Research Team
H
Henry T Shu, BS
B
Babar Shafiq, MD, MSPT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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Published Research Related To This Trial
Management of Acute Compartment Syndrome.
Col Patrick M Osborn, Andrew H Schmidt
https://pubmed.ncbi.nlm.nih.gov/31977609Sedation Practice in Extracorporeal Membrane Oxygenation-Treated Patients with Acute Respiratory Distress Syndrome: A Retrospective Study.
Julian deBacker, Erik Tamberg, Laveena Munshi...
https://pubmed.ncbi.nlm.nih.gov/29045280Tissue pressure measurements as a determinant for the need of fasciotomy.
T E Whitesides, T C Haney, K Morimoto...
https://pubmed.ncbi.nlm.nih.gov/1192674Intracompartmental Pressure Monitoring Using a Handheld Pressure Monitoring System.
Matthew A Halanski, Michael R Morris, Benjamin Lee Harper...
https://pubmed.ncbi.nlm.nih.gov/30473914Continuous Intracompartmental Pressure Monitoring for Acute Compartment Syndrome.
Andrew D Duckworth, Margaret M McQueen
https://pubmed.ncbi.nlm.nih.gov/30881744Continuous compartment pressure monitoring vs. clinical monitoring in tibial diaphyseal fractures.
O Q Al-Dadah, C Darrah, A Cooper...
https://pubmed.ncbi.nlm.nih.gov/18656869Comparison of Three Devices to Measure Pressure for Acute Compartment Syndrome.
Geraldine Merle, Marianne Comeau-Gauthier, Vahid Tayari...
https://pubmed.ncbi.nlm.nih.gov/32074299