Compartment Syndrome of LegVA-ECMONCT05830721
Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
A study of Compartment Syndrome of Leg and Extracorporeal Membrane Oxygenation Complication, run by Johns Hopkins University at 1 site in United States.
Trial summary
Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO). ACS is a type of limb ischemia, which means that the limb, such as the arm or leg, loses blood flow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication, Limb Ischemia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age
- Peripheral Venoarterial-Extracorporeal membrane oxygenation
- Sedated
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Babar Shafiq, MD, MSPT, 443-287-7847, bshafiq2@jhmi.edu
Henry T Shu, 2408050284, hshu5@jhmi.edu
About this study
Official title: Continuous Compartment Pressure Monitoring for Compartment Syndrome in Venoarterial-Extracorporeal Membrane Oxygenation Patients - A Preliminary Feasibility Study
Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO). ACS is a type of limb ischemia, which means that the limb, such as the arm or leg, loses blood flow. Patients on ECMO can develop this condition for many reasons, but most commonly from the ECMO procedure itself. This most commonly involves the leg. Key symptoms of ACS include severe pain, loss of pulses, loss of feeling, and inability to move the limb. However, because patients on ECMO are often sedated, ACS is difficult to diagnose as patients can not report symptoms. As a result, the only available tool for diagnosing ACS may be measurement of pressures in the limb. This is normally done with a needle-device, which is inserted into the leg for a single measurement. However, a recently developed device, called the MY01 Continuous Compartment Pressure Monitor, allows for continuous pressure readings instead of a single measurement. Multiple measurements may allow for much greater accuracy in diagnosing ACS, which may result in faster time to surgery and potentially save more limbs than single measurements. This device may also be less invasive than an older method of continuous pressure measuring, which uses a needle and tubing that is 14-gauge in size. Therefore, this study aims to compare 3 different types of methods for diagnosing ACS in patients on ECMO, which are 1) Standard of Care, 2) Standard of Care and MY01, and 3)Standard of Care and 14-gauge slit catheter.
Read the detailed description
Acute compartment syndrome (ACS) is a surgical emergency that threatens limb viability and can develop in patients on extracorporeal membrane oxygenation (ECMO). ACS typically develops as a complication secondary to peripheral arterial cannulation and is more common in patients on peripheral veno-arterial (VA) ECMO. The pathophysiologic mechanism of ACS implicates a dramatic increase in compartmental pressures due to the non-compliance of the surrounding osteofascial structures. Without sufficient time for compensatory angiogenesis, the marked fluid extravasation and inflammation within the rigid compartment persists. This increase in pressure leads to compression of neurovascular structures, causing or further perpetuating any pre-existing limb ischemia. The underlying cause of the increased compartmental pressures may be due to a variety of causes in these ECMO patients without a history of trauma, such as ischemia and rhabdomyolysis due to direct disruption of arterial flow (i.e. arterial thromboembolism), obstruction of venous flow (i.e. deep vein thrombosis), direct hemorrhage into the compartment from coagulopathy, or reperfusion injury due to calcium overload and microvascular dysfunction. The treatment of ACS is timely (less than 6 hours from diagnosis) fasciotomy, which is limb-saving.
In awake patients, ACS is a clinical diagnosis relying on medical history, visual examination, palpation of pulses, and symptoms of pallor, paresthesia, out-of-proportion pain with passive stretch, and paresis. Though more technically demanding perhaps, duplex/doppler ultrasound may also be employed as an imaging technique to visualize blood flow and characterize the extent of any obstruction underlying the ischemia. Since the mainstay of diagnosis remains to be the subjective pain of the patient, the diagnosis of ACS in ECMO patients is challenged by the fact that patients on ECMO are typically intubated and receiving sedative medications. Thus, compartment pressure measurements >30 mmHg may be the only available diagnostic finding in addition to clinical suspicion based on history and tense muscular compartments for diagnosing ACS.
Traditionally, the standard of care for measuring intracompartmental pressure has been using a needle compartment pressure measuring device (Ex. Stryker needle). Some institutions also use a continuous compartment pressure measuring device in the form of a 14-gauge slit catheter attached to a pressure transducer. The main drawback with utilizing the needle compartment measuring device is that it only provides a single time point recording and is difficult to employ for repetitive use. While using the 14-gauge catheter and transducer offers continuous monitoring, this method creates an additional line to manage for patients on ECMO and runs the risk of failing due to clot formation, especially in patients without anticoagulative measures. In summary, diagnosis of ACS in ECMO patients is challenging, and clinicians currently lack a method for accurate, reliable, and continuous measurement of intracompartmental pressure that is well-tolerated.
Employing digital micro sensing technology, the MY01 Continuous Compartmental Pressure Monitor (NXTSens Inc., Montreal, Canada) is a high-precision, implantable device that can continuously measure intracompartmental pressure. Having shown over 600% improved accuracy when compared to standard compartment pressure measuring devices, this advanced sensory microsystem can provide pressures with an accuracy of ±0.008 mmHg, which are then relayed to a cloud storage database as well as the MY01 mobile application for easy accessibility. With such reliable and real-time continuous pressure monitoring, MY01 may be the optimal diagnostic tool for ACS in patients on ECMO and lead to more prompt, limb-saving surgical fasciotomies.
Therefore, the investigators hypothesize that the MY01 device in conjunction with current standard of care will help identify which patients on VA-ECMO have ACS more precisely than current standard of care alone, which includes physical exam findings and single timepoint needle compartment measurement. Additionally, the investigators hypothesize that the MY01 device will be less invasive and easier to use than previously described methods of continuous compartment pressure monitoring utilizing a 14-gauge slit catheter.
- Conditions
- Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication, Limb Ischemia, Limb Ischemia, Critical
- Being tested
- MY01 + Standard of Care, 14-Gauge Slit Catheter + Standard of Care, Standard of Care
- Keywords
- Compartment Syndrome, Venoarterial Extracorporeal Membrane Oxygenation, Compartment Pressure Measurement, ECMO
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY01 + Standard of CareDevice
In addition to standard of care, the MY01 device will be inserted by an orthopedic surgeon into the leg on the same side as the ECMO tubing. This will occur within 6 hours of the start of ECMO. Insertion of the device involves a needle, which is removed once the device is inserted. Monitoring of the device will occur as described by the device manufacturer, which includes a mobile application. If at any time the compartment pressures suggest that there may be ACS, an orthopedic surgeon will be called to perform a physical exam. If the physical exam supports the diagnosis of ACS, then an additional pressure measurement with a needle may be also taken to confirm the measurement. If the diagnosis of ACS is made, the decision to proceed with surgery, or fasciotomy, will be a joint decision made by entire team. Monitoring of with the device will be done for 24 hours. The device will be removed after 24 hours or if the diagnosis of ACS is made.
14-Gauge Slit Catheter + Standard of CareDevice
For the 14-gauge slit catheter group, the exact same protocol will be followed as the MY01 group. The 14-gauge slit catheter consists of tubing that is 14-gauge in size, which is inserted into the leg with a needle. The needle will be removed once the tubing is inserted. The tubing is then connected to a monitor, which will display the pressure in the leg. Just like the MY01 group, the leg will be numbed and cleaned before the tube is inserted in the leg. Instead of the data being recorded on a mobile device, a nurse or nurse technician will document pressure readings every 4 hours for a total of 24 hours. Once monitoring is finished, the 14-gauge slit catheter will be removed from the leg.
Standard of CareOther
If assigned to standard of care, the participant will undergo monitoring within 1 hour of the start of ECMO. For standard of care group, this will involve monitoring the leg with the ECMO tubing with physical exam every 4 hours for the first 24 hours. This will be performed by a trained nurse. If at any time there is suspicion for ACS, the physical exam will be verified by an orthopedic surgeon. The orthopedic surgeon will decide if pressure measurements will be necessary. If so, then a single pressure measurement from each compartment will be taken with a needle device. If the ACS diagnosis is made, any further monitoring of that leg is stopped. The decision to proceed with surgery, or fasciotomy, will be a joint decision made by entire team, which includes surgeons and medical doctors. This is currently the standard of care at the Johns Hopkins Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | This arm involves standard of care monitoring. Receives: Other: Standard of Care |
| MY01 + standard of care group | Experimental | This arm involves insertion of the MY01 device into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures. Receives: Device: MY01 + Standard of Care; Other: Standard of Care |
| 14-gauge slit catheter monitor + standard of care | Experimental | This arm involves insertion of the 14g slit catheter into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures. Receives: Device: 14-Gauge Slit Catheter + Standard of Care; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Diagnosed Compartment syndrome
Diagnosis of compartment syndrome
Measured: Up to end of hospitalization, which can be up to 1 year
Number of Participants that Require Amputation
If amputation is performed during hospitalization
Measured: Up to end of hospitalization, which can be up to 1 year
Number of Deaths During Hospitalization
Mortality
Measured: Up to end of hospitalization, which can be up to 1 year
Number of Participants with Amputation-free survival
Survival of hospitalization without amputation
Measured: Up to end of hospitalization, which can be up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start2 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Compartment Syndrome of LegStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be an open-label prospective randomized controlled trial with 3 parallel groups.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Babar Shafiq, MD, MSPT, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830721
- Sponsor's protocol ID
- IRB00370480
- Acronym
- VA-ECMO
- Status last verified
- Dec 2025
- First submitted
- 30 Mar 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data sharing is not planned for this study.
Publications
Bonicolini E, Martucci G, Simons J, Raffa GM, Spina C, Lo Coco V, Arcadipane A, Pilato M, Lorusso R. Limb ischemia in peripheral veno-arterial extracorporeal membrane oxygenation: a narrative review of incidence, prevention, monitoring, and treatment. Crit Care. 2019 Jul 30;23(1):266. doi: 10.1186/s13054-019-2541-3.
PubMed 31362770Osborn CPM, Schmidt AH. Management of Acute Compartment Syndrome. J Am Acad Orthop Surg. 2020 Feb 1;28(3):e108-e114. doi: 10.5435/JAAOS-D-19-00270.
PubMed 31977609Lundy DW, Bruggers JL. Management of Missed Compartment Syndrome. 2019 Sep 3. In: Mauffrey C, Hak DJ, Martin III MP, editors. Compartment Syndrome: A Guide to Diagnosis and Management [Internet]. Cham (CH): Springer; 2019. Chapter 11. Available from http://www.ncbi.nlm.nih.gov/books/NBK553895/
PubMed 32091728deBacker J, Tamberg E, Munshi L, Burry L, Fan E, Mehta S. Sedation Practice in Extracorporeal Membrane Oxygenation-Treated Patients with Acute Respiratory Distress Syndrome: A Retrospective Study. ASAIO J. 2018 Jul/Aug;64(4):544-551. doi: 10.1097/MAT.0000000000000658.
PubMed 29045280Whitesides TE, Haney TC, Morimoto K, Harada H. Tissue pressure measurements as a determinant for the need of fasciotomy. Clin Orthop Relat Res. 1975 Nov-Dec;(113):43-51. doi: 10.1097/00003086-197511000-00007.
PubMed 1192674Halanski MA, Morris MR, Lee Harper B, Doro C. Intracompartmental Pressure Monitoring Using a Handheld Pressure Monitoring System. JBJS Essent Surg Tech. 2015 Mar 25;5(1):e6. doi: 10.2106/JBJS.ST.N.00020. eCollection 2015 Feb 25.
PubMed 30473914Duckworth AD, McQueen MM. Continuous Intracompartmental Pressure Monitoring for Acute Compartment Syndrome. JBJS Essent Surg Tech. 2013 Jul 10;3(3):e13. doi: 10.2106/JBJS.ST.M.00023. eCollection 2014 Sep.
PubMed 30881744Al-Dadah OQ, Darrah C, Cooper A, Donell ST, Patel AD. Continuous compartment pressure monitoring vs. clinical monitoring in tibial diaphyseal fractures. Injury. 2008 Oct;39(10):1204-9. doi: 10.1016/j.injury.2008.03.029. Epub 2008 Jul 25.
PubMed 18656869Merle G, Comeau-Gauthier M, Tayari V, Kezzo MN, Kasem C, Al-Kabraiti F, Laverdiere C, Xereas G, Harvey EJ. Comparison of Three Devices to Measure Pressure for Acute Compartment Syndrome. Mil Med. 2020 Jan 7;185(Suppl 1):77-81. doi: 10.1093/milmed/usz305.
PubMed 32074299
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Compartment Pressure Monitoring for Compartment Syndrome in Venoarterial-Extracorporeal Membrane Oxygenation Patients - A Preliminary Feasibility Study
- ClinicalTrials.gov ID
- NCT05830721
- Acronym / sponsor ID
- VA-ECMO / IRB00370480
- Conditions
- Compartment Syndrome of Leg, Extracorporeal Membrane Oxygenation Complication, Limb Ischemia, Limb Ischemia, Critical
- Keywords
- Compartment Syndrome, Venoarterial Extracorporeal Membrane Oxygenation, Compartment Pressure Measurement, ECMO
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO). ACS is a type of limb ischemia, which means that the limb, such as the arm or leg, loses blood flow. Patients on ECMO can develop this condition for many reasons, but most commonly from the ECMO procedure itself. This most commonly involves the leg. Key symptoms of ACS include severe pain, loss of pulses, loss of feeling, and inability to move the limb. However, because patients on ECMO are often sedated, ACS is difficult to diagnose as patients can not report symptoms. As a result, the only available tool for diagnosing ACS may be measurement of pressures in the limb. This is normally done with a needle-device, which is inserted into the leg for a single measurement. However, a recently developed device, called the MY01 Continuous Compartment Pressure Monitor, allows for continuous pressure readings instead of a single measurement. Multiple measurements may allow for much greater accuracy in diagnosing ACS, which may result in faster time to surgery and potentially save more limbs than single measurements. This device may also be less invasive than an older method of continuous pressure measuring, which uses a needle and tubing that is 14-gauge in size. Therefore, this study aims to compare 3 different types of methods for diagnosing ACS in patients on ECMO, which are 1) Standard of Care, 2) Standard of Care and MY01, and 3)Standard of Care and 14-gauge slit catheter.
Detailed description
Acute compartment syndrome (ACS) is a surgical emergency that threatens limb viability and can develop in patients on extracorporeal membrane oxygenation (ECMO). ACS typically develops as a complication secondary to peripheral arterial cannulation and is more common in patients on peripheral veno-arterial (VA) ECMO. The pathophysiologic mechanism of ACS implicates a dramatic increase in compartmental pressures due to the non-compliance of the surrounding osteofascial structures. Without sufficient time for compensatory angiogenesis, the marked fluid extravasation and inflammation within the rigid compartment persists. This increase in pressure leads to compression of neurovascular structures, causing or further perpetuating any pre-existing limb ischemia. The underlying cause of the increased compartmental pressures may be due to a variety of causes in these ECMO patients without a history of trauma, such as ischemia and rhabdomyolysis due to direct disruption of arterial flow (i.e. arterial thromboembolism), obstruction of venous flow (i.e. deep vein thrombosis), direct hemorrhage into the compartment from coagulopathy, or reperfusion injury due to calcium overload and microvascular dysfunction. The treatment of ACS is timely (less than 6 hours from diagnosis) fasciotomy, which is limb-saving.
In awake patients, ACS is a clinical diagnosis relying on medical history, visual examination, palpation of pulses, and symptoms of pallor, paresthesia, out-of-proportion pain with passive stretch, and paresis. Though more technically demanding perhaps, duplex/doppler ultrasound may also be employed as an imaging technique to visualize blood flow and characterize the extent of any obstruction underlying the ischemia. Since the mainstay of diagnosis remains to be the subjective pain of the patient, the diagnosis of ACS in ECMO patients is challenged by the fact that patients on ECMO are typically intubated and receiving sedative medications. Thus, compartment pressure measurements >30 mmHg may be the only available diagnostic finding in addition to clinical suspicion based on history and tense muscular compartments for diagnosing ACS.
Traditionally, the standard of care for measuring intracompartmental pressure has been using a needle compartment pressure measuring device (Ex. Stryker needle). Some institutions also use a continuous compartment pressure measuring device in the form of a 14-gauge slit catheter attached to a pressure transducer. The main drawback with utilizing the needle compartment measuring device is that it only provides a single time point recording and is difficult to employ for repetitive use. While using the 14-gauge catheter and transducer offers continuous monitoring, this method creates an additional line to manage for patients on ECMO and runs the risk of failing due to clot formation, especially in patients without anticoagulative measures. In summary, diagnosis of ACS in ECMO patients is challenging, and clinicians currently lack a method for accurate, reliable, and continuous measurement of intracompartmental pressure that is well-tolerated.
Employing digital micro sensing technology, the MY01 Continuous Compartmental Pressure Monitor (NXTSens Inc., Montreal, Canada) is a high-precision, implantable device that can continuously measure intracompartmental pressure. Having shown over 600% improved accuracy when compared to standard compartment pressure measuring devices, this advanced sensory microsystem can provide pressures with an accuracy of ±0.008 mmHg, which are then relayed to a cloud storage database as well as the MY01 mobile application for easy accessibility. With such reliable and real-time continuous pressure monitoring, MY01 may be the optimal diagnostic tool for ACS in patients on ECMO and lead to more prompt, limb-saving surgical fasciotomies.
Therefore, the investigators hypothesize that the MY01 device in conjunction with current standard of care will help identify which patients on VA-ECMO have ACS more precisely than current standard of care alone, which includes physical exam findings and single timepoint needle compartment measurement. Additionally, the investigators hypothesize that the MY01 device will be less invasive and easier to use than previously described methods of continuous compartment pressure monitoring utilizing a 14-gauge slit catheter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study will be an open-label prospective randomized controlled trial with 3 parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CareThis arm involves standard of care monitoring. |
| MY01 + standard of care group | Experimental | Device: MY01 + Standard of Care, Other: Standard of CareThis arm involves insertion of the MY01 device into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures. |
| 14-gauge slit catheter monitor + standard of care | Experimental | Device: 14-Gauge Slit Catheter + Standard of Care, Other: Standard of CareThis arm involves insertion of the 14g slit catheter into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years of age
- Peripheral Venoarterial-Extracorporeal membrane oxygenation
- Sedated
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MY01 + Standard of CareIn addition to standard of care, the MY01 device will be inserted by an orthopedic surgeon into the leg on the same side as the ECMO tubing. This will occur within 6 hours of the start of ECMO. Insertion of the device involves a needle, which is removed once the device is inserted. Monitoring of the device will occur as described by the device manufacturer, which includes a mobile application. If at any time the compartment pressures suggest that there may be ACS, an orthopedic surgeon will be called to perform a physical exam. If the physical exam supports the diagnosis of ACS, then an additional pressure measurement with a needle may be also taken to confirm the measurement. If the diagnosis of ACS is made, the decision to proceed with surgery, or fasciotomy, will be a joint decision made by entire team. Monitoring of with the device will be done for 24 hours. The device will be removed after 24 hours or if the diagnosis of ACS is made. | Device | MY01 + standard of care group |
| 14-Gauge Slit Catheter + Standard of CareFor the 14-gauge slit catheter group, the exact same protocol will be followed as the MY01 group. The 14-gauge slit catheter consists of tubing that is 14-gauge in size, which is inserted into the leg with a needle. The needle will be removed once the tubing is inserted. The tubing is then connected to a monitor, which will display the pressure in the leg. Just like the MY01 group, the leg will be numbed and cleaned before the tube is inserted in the leg. Instead of the data being recorded on a mobile device, a nurse or nurse technician will document pressure readings every 4 hours for a total of 24 hours. Once monitoring is finished, the 14-gauge slit catheter will be removed from the leg. | Device | 14-gauge slit catheter monitor + standard of care |
| Standard of CareIf assigned to standard of care, the participant will undergo monitoring within 1 hour of the start of ECMO. For standard of care group, this will involve monitoring the leg with the ECMO tubing with physical exam every 4 hours for the first 24 hours. This will be performed by a trained nurse. If at any time there is suspicion for ACS, the physical exam will be verified by an orthopedic surgeon. The orthopedic surgeon will decide if pressure measurements will be necessary. If so, then a single pressure measurement from each compartment will be taken with a needle device. If the ACS diagnosis is made, any further monitoring of that leg is stopped. The decision to proceed with surgery, or fasciotomy, will be a joint decision made by entire team, which includes surgeons and medical doctors. This is currently the standard of care at the Johns Hopkins Hospital. | Other | 14-gauge slit catheter monitor + standard of care, MY01 + standard of care group, Standard of Care |
Primary outcome
Number of Participants with Diagnosed Compartment syndrome
Time frame: Up to end of hospitalization, which can be up to 1 year
Diagnosis of compartment syndrome
Number of Participants that Require Amputation
Time frame: Up to end of hospitalization, which can be up to 1 year
If amputation is performed during hospitalization
Number of Deaths During Hospitalization
Time frame: Up to end of hospitalization, which can be up to 1 year
Mortality
Number of Participants with Amputation-free survival
Time frame: Up to end of hospitalization, which can be up to 1 year
Survival of hospitalization without amputation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 31362770Bonicolini E, Martucci G, Simons J, Raffa GM, Spina C, Lo Coco V, Arcadipane A, Pilato M, Lorusso R. Limb ischemia in peripheral veno-arterial extracorporeal membrane oxygenation: a narrative review of incidence, prevention, monitoring, and treatment. Crit Care. 2019 Jul 30;23(1):266. doi: 10.1186/s13054-019-2541-3.
- Background: PubMed 31977609Osborn CPM, Schmidt AH. Management of Acute Compartment Syndrome. J Am Acad Orthop Surg. 2020 Feb 1;28(3):e108-e114. doi: 10.5435/JAAOS-D-19-00270.
- Background: PubMed 32091728Lundy DW, Bruggers JL. Management of Missed Compartment Syndrome. 2019 Sep 3. In: Mauffrey C, Hak DJ, Martin III MP, editors. Compartment Syndrome: A Guide to Diagnosis and Management [Internet]. Cham (CH): Springer; 2019. Chapter 11. Available from http://www.ncbi.nlm.nih.gov/books/NBK553895/
- Background: PubMed 29045280deBacker J, Tamberg E, Munshi L, Burry L, Fan E, Mehta S. Sedation Practice in Extracorporeal Membrane Oxygenation-Treated Patients with Acute Respiratory Distress Syndrome: A Retrospective Study. ASAIO J. 2018 Jul/Aug;64(4):544-551. doi: 10.1097/MAT.0000000000000658.
- Background: PubMed 1192674Whitesides TE, Haney TC, Morimoto K, Harada H. Tissue pressure measurements as a determinant for the need of fasciotomy. Clin Orthop Relat Res. 1975 Nov-Dec;(113):43-51. doi: 10.1097/00003086-197511000-00007.
- Background: PubMed 30473914Halanski MA, Morris MR, Lee Harper B, Doro C. Intracompartmental Pressure Monitoring Using a Handheld Pressure Monitoring System. JBJS Essent Surg Tech. 2015 Mar 25;5(1):e6. doi: 10.2106/JBJS.ST.N.00020. eCollection 2015 Feb 25.
- Background: PubMed 30881744Duckworth AD, McQueen MM. Continuous Intracompartmental Pressure Monitoring for Acute Compartment Syndrome. JBJS Essent Surg Tech. 2013 Jul 10;3(3):e13. doi: 10.2106/JBJS.ST.M.00023. eCollection 2014 Sep.
- Background: PubMed 18656869Al-Dadah OQ, Darrah C, Cooper A, Donell ST, Patel AD. Continuous compartment pressure monitoring vs. clinical monitoring in tibial diaphyseal fractures. Injury. 2008 Oct;39(10):1204-9. doi: 10.1016/j.injury.2008.03.029. Epub 2008 Jul 25.
- Background: PubMed 32074299Merle G, Comeau-Gauthier M, Tayari V, Kezzo MN, Kasem C, Al-Kabraiti F, Laverdiere C, Xereas G, Harvey EJ. Comparison of Three Devices to Measure Pressure for Acute Compartment Syndrome. Mil Med. 2020 Jan 7;185(Suppl 1):77-81. doi: 10.1093/milmed/usz305.
- Individual participant dataSharing planned: No. Data sharing is not planned for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Babar Shafiq, MD, MSPT principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Compartment Syndrome of Leg and Extracorporeal Membrane Oxygenation Complication, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henry T Shu, BS (2408050284, hshu5@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Diagnosed Compartment syndrome (time frame: Up to end of hospitalization, which can be up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05830721, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.