Ischemia Detection During Development of Acute Compartment Syndrome

N/ANot Yet RecruitingNCT06079255

Oslo University Hospital60 enrolled

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. 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.

Study Type

OBSERVATIONAL

Conditions

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

Interventions

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

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

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

Locations (1)

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Tissue CO2-level

Tissue CO2-level (kPa) during insertion period

Time frame: 10 days

Secondary Outcomes

Bleeding

Amount of blood from insertion site (ml)

Time frame: 10 days

Infection

Infection from insertion site at the discretion of the investigator (yes or no)

Time frame: 30 days

Pain at sensor insertion site

Pain at the insertion site measured by Numeric Rating Scale (0= no pain, 10= maximum pain)

Time frame: 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)

Time frame: 10 days

Color of the lower leg

Skin color of the injured lower leg (Blue/Pink/Pale/Normal) during hospitalisation

Time frame: 10 days

Paresthesia of the lower leg

Paresthesia of the injured lower leg (Yes/No) during hospitalisation

Time frame: 10 days

Paralysis of the lower leg

Paralysis of the injured lower leg (Yes/No) during hospitalisation

Time frame: 10 days

Lenght of sensor implantation time

Central 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

Data from ClinicalTrials.gov

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