NCT06079255

Ischemia Detection During Development of Acute Compartment Syndrome

Early Ischemia Detection by a Tissue CO2-sensor During Development of Acute Compartment Syndrome

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DEVICE	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)

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-02-28
• Completion: 2027-10-30
• First posted: 2023-10-12
• Last updated: 2025-03-25

Locations

1 site across 1 country: Norway