Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients

NCT05830721 | Recruiting DMC FDA Device

• 1 other identifier: IRB00370480
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Diagnosed Compartment syndrome

  Diagnosis of compartment syndrome

  Up to end of hospitalization, which can be up to 1 year

• Number of Participants that Require Amputation

  If amputation is performed during hospitalization

  Up to end of hospitalization, which can be up to 1 year

• Number of Deaths During Hospitalization

  Mortality

  Up to end of hospitalization, which can be up to 1 year

• Number of Participants with Amputation-free survival

  Survival of hospitalization without amputation

  Up to end of hospitalization, which can be up to 1 year

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

This arm involves standard of care monitoring.

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.

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.

Device: 14-Gauge Slit Catheter + Standard of Care; Other: Standard of Care

Interventions

MY01 + Standard of Care DEVICE

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.

MY01 + standard of care group

14-Gauge Slit Catheter + Standard of Care DEVICE

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.

14-gauge slit catheter monitor + standard of care

Standard of Care OTHER

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; MY01 + standard of care group; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age
• Peripheral Venoarterial-Extracorporeal membrane oxygenation
• Sedated

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 31362770 BACKGROUND

• 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.

  PMID: 31977609 BACKGROUND

• 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/

  PMID: 32091728 BACKGROUND

• 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.

  PMID: 29045280 BACKGROUND

• 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.

  PMID: 1192674 BACKGROUND

• 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.

  PMID: 30473914 BACKGROUND

• 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.

  PMID: 30881744 BACKGROUND

• 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.

  PMID: 18656869 BACKGROUND

• 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.

  PMID: 32074299 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Compartment Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Babar Shafiq, MD, MSPT

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry T Shu, BS

CONTACT

2408050284; hshu5@jhmi.edu

Babar Shafiq, MD, MSPT

CONTACT

2024218697; bshafiq2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There will be no masking.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be an open-label prospective randomized controlled trial with 3 parallel groups.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 26, 2023
• Study Start: January 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)