← Back to Search

MY01 + standard of care group for Compartment Syndrome (VA-ECMO Trial)

N/A

Recruiting

Led By Babar Shafiq, MD, MSPT

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sedated

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

VA-ECMO Trial Summary

This trial aims to compare different methods of diagnosing acute compartment syndrome (ACS) in patients on extracorporeal membrane oxygenation (ECMO). ACS is a condition where a limb, like an

Who is the study for?

This trial is for adults over 18 on VA-ECMO who are sedated. It's designed to help those at risk of acute compartment syndrome, a condition where limbs lose blood flow often due to ECMO itself.Check my eligibility

What is being tested?

The study compares three methods for diagnosing ACS in ECMO patients: standard care alone, standard care with continuous pressure monitoring using the MY01 device, and standard care plus a traditional needle method (14-gauge slit catheter).See study design

What are the potential side effects?

Potential side effects may include discomfort or pain from the pressure monitoring devices, possible skin infection at the insertion site, and bruising. The MY01 device might offer less invasive monitoring compared to the traditional needle method.

VA-ECMO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently under sedation.

VA-ECMO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to end of hospitalization, which can be up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Deaths During Hospitalization

Number of Participants that Require Amputation

Number of Participants with Amputation-free survival

+1 more

VA-ECMO Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: MY01 + standard of care groupExperimental Treatment2 Interventions

This arm involves insertion of the MY01 device into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures.

Group II: 14-gauge slit catheter monitor + standard of careExperimental Treatment2 Interventions

This arm involves insertion of the 14g slit catheter into the same leg as the arterial ECMO tubing to continuously monitor compartment pressures.

Group III: Standard of CareActive Control1 Intervention

This arm involves standard of care monitoring.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,491 Total Patients Enrolled

Babar Shafiq, MD, MSPTPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to actively enroll participants for this research study?

"Indeed, the details provided on clinicaltrials.gov indicate that this study is actively seeking participants. The trial was originally posted on January 2nd, 2024 and last updated on January 3rd, 2024. There is a need for six individuals to enroll in the study at one specific location."

Answered by AI

What is the current number of participants being recruited for this research project?

"Indeed, the details on clinicaltrials.gov indicate that this ongoing clinical trial is actively seeking participants. The initial posting date was recorded as 1/2/2024 and it was last updated on 1/3/2024. The study aims to enroll a total of 6 patients at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05830721.

All > Ecmo