Ischemia Detection During Development of Acute Compartment Syndrome

NCT ID: NCT06079255

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2027-10-30

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IscAlert sensor in patient with risk of acute compartment syndrome

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.

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

Intervention Type: DEVICE

of the replanted extremity Insertion of a CO2- and temperature sensor(s) (IscAlert) in the anterior compartment of a lower limb (leg)

Interventions

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

of the replanted extremity Insertion of a CO2- and temperature sensor(s) (IscAlert) in the anterior compartment of a lower limb (leg)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensocure AS

INDUSTRY

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

John Clarke-Jenssen

Chief Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Clarke-Jenssen, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Central Contacts

John Clarke-Jenssen, MD, PhD.

Role: CONTACT

uxclaj@ous-hf.no

23027447 ext. +47

Tor Inge Tønnessen, MD, Ph.D.

Role: CONTACT

t.i.tonnessen@medisin.uio.no

91700717 ext. +47

Facility Contacts

Rolf B. Riise, MD

Role: primary

riise@ous-hf.no

23076044 ext. +47

Other Identifiers

IDEA

Identifier Type: -

Identifier Source: org_study_id