Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients
NCT ID: NCT05830721
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
6 participants
INTERVENTIONAL
2024-01-02
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care
This arm involves standard of care monitoring.
Standard of Care
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.
MY01 + standard of care group
This arm involves insertion of the MY01 device into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures.
MY01 + Standard of Care
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.
Standard of Care
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.
14-gauge slit catheter monitor + standard of care
This arm involves insertion of the 14g slit catheter into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures.
14-Gauge Slit Catheter + Standard of Care
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 Care
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MY01 + Standard of Care
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 Care
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 Care
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Peripheral Venoarterial-Extracorporeal membrane oxygenation
* Sedated
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johns Hopkins University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Babar Shafiq, MD, MSPT
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Babar Shafiq, MD, MSPT
Role: primary
Henry T Shu
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
Osborn 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.
Lundy 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/
deBacker 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.
Whitesides 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.
Halanski 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.
Duckworth 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.
Al-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.
Merle 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00370480
Identifier Type: -
Identifier Source: org_study_id