Ischemia Detection During Development of Acute Compartment Syndrome (IDEA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemia Limb; Compartment Syndrome of Leg; Carbon Dioxide; Blood Circulation Disorder; Biosensing Techniques
• Intervention / Treatment: Device: IscAlert sensor(s) in patient with risk of 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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: John Clarke-Jenssen, MD, PhD.; Phone Number: +47 23027447; Email: uxclaj@ous-hf.no
• Study Contact Backup: Name: Tor Inge Tønnessen, MD, Ph.D.; Phone Number: +47 91700717; Email: t.i.tonnessen@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital
    • Contact: Rolf B. Riise, MD; Phone Number: +47 23076044; Email: riise@ous-hf.no
    • Sub-Investigator: Sarmad Shafiq, MD
    • Sub-Investigator: Monica Jensen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IscAlert sensor in patient with risk of acute compartment syndrome; 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; of the replanted extremity Insertion of a CO2- and temperature sensor(s) (IscAlert) in the anterior compartment of a lower limb (leg)

What is the study measuring?

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
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
IscAlert functionality	Number of hours with a well-functioning sensor (giving CO2- and temperature data)	10 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
Tissue temperature level	Tissue temperature level (grade Celcius) during insertion period	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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Sensocure AS
• Investigators: Principal Investigator: John Clarke-Jenssen, MD, PhD., Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Ischemia; Carbon dioxide; Biosensor; Orthopedic surgery; Limb; Acute compartment syndrome
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Pathologic Processes; Disease; Syndrome; Ischemia; Compartment Syndromes
• Other Study ID Numbers: IDEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No