Ischemia Detection During Development of Acute Compartment Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IscAlert sensor(s) in patient with risk of acute compartment syndrome.
- Who it may be relevant to
- Registry conditions: Ischemia Limb, Blood Circulation Disorder, Carbon Dioxide, Biosensing Techniques. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Ischemia Detection by a Tissue CO2-sensor During Development of Acute Compartment Syndrome
Overview
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.
Interventions
- 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)
Primary outcome measures
- Tissue CO2-level [Time frame: 10 days]
Secondary outcome measures (12)
- Bleeding [Time frame: 10 days]
- Infection [Time frame: 30 days]
- Pain at sensor insertion site [Time frame: 30 days]
- Pain in the lower leg during hospitalisation [Time frame: 10 days]
- Color of the lower leg [Time frame: 10 days]
- Paresthesia of the lower leg [Time frame: 10 days]
- Paralysis of the lower leg [Time frame: 10 days]
- Lenght of sensor implantation time [Time frame: 10 days]
- Time to discovery of reduced blood flow in lower leg [Time frame: 10 days]
- Number of re-operations [Time frame: 30 days]
- Number of skin grafts performed [Time frame: 1 year]
- Number of limb amputations performed [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Norway · 1 center
- Oslo University Hospital — Oslo
Identifiers
NCT: NCT06079255 · IDEA