Clinical trial NCT06079255: Ischemia Detection During Development of Acute Compartment Syndrome
Official title: Early Ischemia Detection by a Tissue CO2-sensor During Development of Acute Compartment Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sensocure AS
First posted: 2023-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Tissue CO2-level
timeFrame: 10 days
Secondary outcomes:
measure: Bleeding
timeFrame: 10 days
measure: Infection
timeFrame: 30 days
measure: Pain at sensor insertion site
timeFrame: 30 days
measure: Pain in the lower leg during hospitalisation
timeFrame: 10 days
measure: Color of the lower leg
timeFrame: 10 days
measure: Paresthesia of the lower leg
timeFrame: 10 days
measure: Paralysis of the lower leg
timeFrame: 10 days
measure: Lenght of sensor implantation time
timeFrame: 10 days
measure: Time to discovery of reduced blood flow in lower leg
timeFrame: 10 days
measure: Number of re-operations
timeFrame: 30 days
measure: Number of skin grafts performed
timeFrame: 1 year
measure: Number of limb amputations performed
timeFrame: 1 year
measure: Number of sensory deficit conditions
timeFrame: 1 year
measure: Number of paralysis conditions
timeFrame: 1 year
measure: Number of rhabdomyolysis conditions
timeFrame: 1 year
measure: Number of limb muscle contractures
timeFrame: 1 year
measure: Number of acute compartment syndrome conditions during hospitalisation
timeFrame: 30 days
measure: Number of acute compartment syndrome conditions after 1 year
timeFrame: 1 year
measure: Incidence of death 1 year
timeFrame: 1 year
measure: Incidence of death during hospitalisation
timeFrame: 30 days
measure: Lenght of stay during primary hospitalisation
timeFrame: 30 days
measure: Number of pack-years
timeFrame: 30 days
measure: Intravenous fluid
timeFrame: 12 hours
measure: Vasoactive drugs
timeFrame: 12 hours
measure: Tissue temperature level
timeFrame: 10 days
measure: IscAlert functionality
timeFrame: 10 days
measure: Intracompartmental pressure
timeFrame: 10 days
measure: Systolic blood pressure during hospitalisation
timeFrame: 10 days
measure: Diastolic blood pressure during hospitalisation
timeFrame: 10 days
measure: Peripheral pulse during hospitalisation
timeFrame: 10 days
measure: Hemoglobin
timeFrame: 10 days
measure: Creatine kinase
timeFrame: 10 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: John Clarke-Jenssen, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: