Ischemia Detection During Development of Acute Compartment Syndrome

Study Overview
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Brief Summary
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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
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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 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. No clinically significant pain, bleeding or infection will occur due to using IscAlert. 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.

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

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

Intervention / Treatment
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* Device: IscAlert sensor(s) in patient with risk of acute compartment syndrome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IscAlert sensor in patient with risk of acute compartment syndrome<br>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<br>* of the replanted extremity Insertion of a CO2- and temperature sensor(s) (IscAlert) in the anterior compartment of a lower limb (leg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue CO2-level | Tissue CO2-level (kPa) during insertion period | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Amount of blood from insertion site (ml) | 10 days | 
| Infection | Infection from insertion site at the discretion of the investigator (yes or no) | 30 days | 
| Pain at sensor insertion site | Pain at the insertion site measured by Numeric Rating Scale (0= no pain, 10= maximum pain) | 30 days | 
| Pain in the lower leg during hospitalisation | Pain in the injured lower leg measured by Numeric Rating Scale (0= no pain, 10= maximum pain) | 10 days | 
| Color of the lower leg | Skin color of the injured lower leg (Blue/Pink/Pale/Normal) during hospitalisation | 10 days | 
| Paresthesia of the lower leg | Paresthesia of the injured lower leg (Yes/No) during hospitalisation | 10 days | 
| Paralysis of the lower leg | Paralysis of the injured lower leg (Yes/No) during hospitalisation | 10 days | 
| Lenght of sensor implantation time | Lenght of sensor implantation time during hospitalisation | 10 days | 
| Time to discovery of reduced blood flow in lower leg | Number of days and hours from primary surgery end to obstructed blood flow is diagnosed. | 10 days | 
| Number of re-operations | Number of reoperations (fasciotomies) caused by acute compartment syndrome | 30 days | 
| Number of skin grafts performed | Number of skin grafts performed caused by sequelae after acute compartment syndrome | 1 year | 
| Number of limb amputations performed | Number of limb amputations performed caused by sequelae after acute compartment syndrome | 1 year | 
| Number of sensory deficit conditions | Number of sensory deficit conditions caused by sequelae after acute compartment syndrome | 1 year | 
| Number of paralysis conditions | Number of paralysis conditions caused by sequelae after acute compartment syndrome | 1 year | 
| Number of rhabdomyolysis conditions | Number of rhabdomyolysis conditions caused by sequelae after acute compartment syndrome | 1 year | 
| Number of limb muscle contractures | Number of limb muscle contractures caused by sequelae after acute compartment syndrome | 1 year | 
| Number of acute compartment syndrome conditions during hospitalisation | Number of acute compartment syndrome conditions during hospitalisation | 30 days | 
| Number of acute compartment syndrome conditions after 1 year | Number of acute compartment syndrome conditions after 1 year | 1 year | 
| Incidence of death 1 year | Mortality 1 year after admission | 1 year | 
| Incidence of death during hospitalisation | Mortality during primary hospitalisation | 30 days | 
| Lenght of stay during primary hospitalisation | Lenght of stay during primary hospitalisation | 30 days | 
| Number of pack-years | Smoking habit; number of pack-years by participants | 30 days | 
| Intravenous fluid | Intravenous fluid given during surgery (ml) | 12 hours | 
| Vasoactive drugs | Vasoactive drugs given during surgery (microgram) | 12 hours | 
| Tissue temperature level | Tissue temperature level (grade Celcius) during insertion period | 10 days | 
| IscAlert functionality | Number of hours with a well-functioning sensor (giving CO2- and temperature data) | 10 days | 
| Intracompartmental pressure | Intracompartmental pressure (mmHg) measured in anterior compartment of the injured leg | 10 days | 
| Systolic blood pressure during hospitalisation | Systolic blood pressure (mmHg) during hospitalisation | 10 days | 
| Diastolic blood pressure during hospitalisation | Diastolic blood pressure (mmHg) during hospitalisation | 10 days | 
| Peripheral pulse during hospitalisation | Peripheral distal pulse (rate/minute) at the injured leg during hospitalisation | 10 days | 
| Hemoglobin | Hemoglobin (g/dL) level during hospitalisation | 10 days | 
| Creatine kinase | Creatine kinase (U/L) level during hospitalisation | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia, Biosensor, Carbon dioxide, Orthopedic surgery, Limb, Acute compartment syndrome