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.
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
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
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
Cohort
Prospective
IscAlert sensor(s) in patient with risk of acute compartment syndrome
Deviceof the replanted extremity Insertion of a CO2- and temperature sensor(s) (IscAlert) in the anterior compartment of a lower limb (leg)
Tissue CO2-level
Tissue CO2-level (kPa) during insertion period
Bleeding
Amount of blood from insertion site (ml)
Infection
Infection from insertion site at the discretion of the investigator (yes or no)
Pain at sensor insertion site
Pain at the insertion site measured by Numeric Rating Scale (0= no pain, 10= maximum pain)
Pain in the lower leg during hospitalisation
Pain in the injured lower leg measured by Numeric Rating Scale (0= no pain, 10= maximum pain)
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Oslo University Hospital
Lead sponsor
Sensocure AS
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
