Ischemia Detection During Development of Acute Compartment Syndrome

Carbon Dioxide Clinical Trial

— IDEA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079255
• Other study ID #: IDEA
• Status: Not yet recruiting
• Start date: December 15, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: John Clarke-Jenssen, MD, PhD.
• Phone: 23027447
• Email: uxclaj[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Sensocure AS

Country where clinical trial is conducted

Norway, 

Outcome

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