Ischemia Detection During Development of Acute Compartment Syndrome

NCT06079255 | Not Yet Recruiting

• 1 other identifier: IDEA
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ischemia; Biosensor; Carbon dioxide; Orthopedic surgery; Limb; Acute compartment syndrome

Outcome Measures

Primary Outcomes (1)

• Tissue CO2-level

  Tissue CO2-level (kPa) during insertion period

  10 days

Secondary Outcomes (32)

• Bleeding

  10 days

• Infection

  30 days

• Pain at sensor insertion site

  30 days

• Pain in the lower leg during hospitalisation

  10 days

• Color of the lower leg

  10 days

Study Arms (1)

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.

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

Interventions

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

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

IscAlert sensor in patient with risk of acute compartment syndrome

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 consecutive patients at risk of acute compartment syndrome of both genders at the age above 18 years who corresponds to inclusion and exclusion criteria at Oslo University Hospital will be included

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sensocure AS: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Clarke-Jenssen, MD, PhD.

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Clarke-Jenssen, MD, PhD.

CONTACT

23027447; uxclaj@ous-hf.no

Tor Inge Tønnessen, MD, Ph.D.

CONTACT

91700717; t.i.tonnessen@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Consultant

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: October 15, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)