RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Continuous Compartment Pressure Monitoring for Compartment Syndrome in Venoarterial-Extracorporeal Membrane Oxygenation Patients - A Preliminary Feasibility Study

Quick Facts

Study Start:2024-01-02
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05830721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ≥18 years of age
  2. * Peripheral Venoarterial-Extracorporeal membrane oxygenation
  3. * Sedated
  1. * Any limb ischemia diagnosis prior to ECMO cannulation
  2. * Any severe extremity trauma that precludes insertion of device
  3. * 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.

Contacts and Locations

Study Contact

Henry T Shu, BS
CONTACT
2408050284
hshu5@jhmi.edu
Babar Shafiq, MD, MSPT
CONTACT
2024218697
bshafiq2@jhmi.edu

Principal Investigator

Babar Shafiq, MD, MSPT
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Babar Shafiq, MD, MSPT, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-02
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-01-02
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Compartment Syndrome
  • Venoarterial Extracorporeal Membrane Oxygenation
  • Compartment Pressure Measurement
  • ECMO

Additional Relevant MeSH Terms

  • Compartment Syndrome of Leg
  • Extracorporeal Membrane Oxygenation Complication
  • Limb Ischemia
  • Limb Ischemia, Critical