Ischemia Detection During Development of Acute Compartment Syndrome (IDEA)

University of Oslo (UIO)

Status: Not yet enrolling

Conditions: Carbon Dioxide; Compartment Syndrome of Leg; Biosensing Techniques; Blood Circulation Disorder; Ischemia Limb

Treatments: Device: IscAlert sensor(s) in patient with risk of acute compartment syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT06079255

IDEA

Details and patient eligibility

About

This is an open, observational, prospective, descriptive, single-centre study including 60 patients. The study is designed to investigate if IscAlert sensor system can be used for reliable and continuous tissue carbon dioxide (pCO2)- and temperature monitoring in muscular tissue in lower extremity in patients at risk of developing acute compartment syndrome.

Full description

This is an open, observational, prospective, descriptive, single-centre study including 60 patients. The study is designed to investigate if IscAlert sensor system can be used for reliable and continuous tissue carbon dioxide (pCO2)- and temperature monitoring in muscular tissue in lower extremity in patients at risk of developing acute compartment syndrome.

The study will provide information regarding the clinical usefulness of tissue perfusion assessment by pCO2 and temperature monitoring in the diagnosis of patients at risk of developing acute compartment syndrome. Additionally, it will provide information regarding limits of pCO2 and temperature in the tissue indicating the need for fasciotomy. A fasciotomy will be performed independent of the measured pCO2 and temperature measurements in the muscle if clinical signs indicate a development of possible acute compartment syndrome. Measures of pain, and number of infections and bleeding caused by (or assumed to be caused by IscAlert) at insertion site will be registered.

The duration of investigation: In a patient: From insertion of first IscAlert™ sensor(s) to discharge from hospital. The sensors will usually be implanted for two days each. Follow up until 30 days after discharge from the hospital. 13 months of inclusion of all patients. There will be one last follow-up visit 1 year after discharge which will only look at sequelae after acute compartment syndrome and not sensors related issues.

Primary Aim: To assess if pCO2-levels when assessed with IscAlert correctly indicate the presence of acute compartment syndrome in muscular tissue in lower extremity in patients at risk of developing acute compartment syndrome.

Hypotheses

1. The pCO2 measurements will be at least 3 kPa higher when assessed with IscAlert in the muscle compartment where acute compartment syndrome develops compared to compartments where acute compartment syndrome does not develop.
2. No clinically significant pain, bleeding or infection will occur due to using IscAlert.
3. The temperature measurements will be lower when assessed with IscAlert in the muscle compartment where acute compartment syndrome develops compared to compartments where acute compartment syndrome does not develop.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have a leg fracture that, perceived by the clinician, could give rise to later developing acute compartment syndrome condition.
• Subject must be 18 years or more.
• Able to sign informed consent.
• Expected cooperation of the patients for the treatment and follow up

Exclusion criteria

• Another study interfering with current study
• Any reason why, in the opinion of the investigator, the patient should not participate.
• Patients where a fasciotomy has already been decided should be performed

Trial design

60 participants in 1 patient group

IscAlert sensor in patient with risk of acute compartment syndrome

Description:

Patients admitted with leg injury at risk of acute compartment syndrome will receive IscAlert sensor(s) in the anterior compartment of the lower limb. A duration of maximum 10 days.

Treatment:

Device: IscAlert sensor(s) in patient with risk of acute compartment syndrome