Ischemia LimbIDEANCT06079255
Ischemia Detection During Development of Acute Compartment Syndrome
An observational study of Ischemia Limb and Blood Circulation Disorder, run by Oslo University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Ischemia Limb, Blood Circulation Disorder, Carbon Dioxide
- What is being tested?
- IscAlert sensor(s) in patient with risk of acute compartment syndrome
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 15 Oct 2025to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Oslo University Hospital
Oslo, 0424
Rolf B. Riise, MD, 23076044 ext. +47, riise@ous-hf.no
Sarmad Shafiq, MD
About this study
Official title: 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.
Read the 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
- 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.
- Conditions
- Ischemia Limb, Blood Circulation Disorder, Carbon Dioxide, Biosensing Techniques, Compartment Syndrome of Leg
- Being tested
- IscAlert sensor(s) in patient with risk of acute compartment syndrome
- Keywords
- Ischemia, Biosensor, Carbon dioxide, Orthopedic surgery, Limb, Acute compartment syndrome
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IscAlert sensor(s) in patient with risk of acute compartment syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue CO2-level
Tissue CO2-level (kPa) during insertion period
Measured: 10 days
Secondary outcomes (32)
Bleeding
Amount of blood from insertion site (ml)
Measured: 10 days
Infection
Infection from insertion site at the discretion of the investigator (yes or no)
Measured: 30 days
Pain at sensor insertion site
Pain at the insertion site measured by Numeric Rating Scale (0= no pain, 10= maximum pain)
Measured: 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)
Measured: 10 days
Color of the lower leg
Skin color of the injured lower leg (Blue/Pink/Pale/Normal) during hospitalisation
Measured: 10 days
Paresthesia of the lower leg
Paresthesia of the injured lower leg (Yes/No) during hospitalisation
Measured: 10 days
Paralysis of the lower leg
Paralysis of the injured lower leg (Yes/No) during hospitalisation
Measured: 10 days
Lenght of sensor implantation time
Lenght of sensor implantation time during hospitalisation
Measured: 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.
Measured: 10 days
Number of re-operations
Number of reoperations (fasciotomies) caused by acute compartment syndrome
Measured: 30 days
Number of skin grafts performed
Number of skin grafts performed caused by sequelae after acute compartment syndrome
Measured: 1 year
Number of limb amputations performed
Number of limb amputations performed caused by sequelae after acute compartment syndrome
Measured: 1 year
Number of sensory deficit conditions
Number of sensory deficit conditions caused by sequelae after acute compartment syndrome
Measured: 1 year
Number of paralysis conditions
Number of paralysis conditions caused by sequelae after acute compartment syndrome
Measured: 1 year
Number of rhabdomyolysis conditions
Number of rhabdomyolysis conditions caused by sequelae after acute compartment syndrome
Measured: 1 year
Number of limb muscle contractures
Number of limb muscle contractures caused by sequelae after acute compartment syndrome
Measured: 1 year
Number of acute compartment syndrome conditions during hospitalisation
Number of acute compartment syndrome conditions during hospitalisation
Measured: 30 days
Number of acute compartment syndrome conditions after 1 year
Number of acute compartment syndrome conditions after 1 year
Measured: 1 year
Incidence of death 1 year
Mortality 1 year after admission
Measured: 1 year
Incidence of death during hospitalisation
Mortality during primary hospitalisation
Measured: 30 days
Lenght of stay during primary hospitalisation
Lenght of stay during primary hospitalisation
Measured: 30 days
Number of pack-years
Smoking habit; number of pack-years by participants
Measured: 30 days
Intravenous fluid
Intravenous fluid given during surgery (ml)
Measured: 12 hours
Vasoactive drugs
Vasoactive drugs given during surgery (microgram)
Measured: 12 hours
Tissue temperature level
Tissue temperature level (grade Celcius) during insertion period
Measured: 10 days
IscAlert functionality
Number of hours with a well-functioning sensor (giving CO2- and temperature data)
Measured: 10 days
Intracompartmental pressure
Intracompartmental pressure (mmHg) measured in anterior compartment of the injured leg
Measured: 10 days
Systolic blood pressure during hospitalisation
Systolic blood pressure (mmHg) during hospitalisation
Measured: 10 days
Diastolic blood pressure during hospitalisation
Diastolic blood pressure (mmHg) during hospitalisation
Measured: 10 days
Peripheral pulse during hospitalisation
Peripheral distal pulse (rate/minute) at the injured leg during hospitalisation
Measured: 10 days
Hemoglobin
Hemoglobin (g/dL) level during hospitalisation
Measured: 10 days
Creatine kinase
Creatine kinase (U/L) level during hospitalisation
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start15 Oct 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia LimbStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sensocure AS
- Responsible party
- Principal investigator, John Clarke-Jenssen, Oslo University Hospital
- Investigators
- John Clarke-Jenssen, MD, PhD., Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079255
- Sponsor's protocol ID
- IDEA
- Acronym
- IDEA
- Status last verified
- Mar 2025
- First submitted
- 6 Oct 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ischemia Detection by a Tissue CO2-sensor During Development of Acute Compartment Syndrome
- ClinicalTrials.gov ID
- NCT06079255
- Acronym / sponsor ID
- IDEA / IDEA
- Conditions
- Ischemia Limb, Blood Circulation Disorder, Carbon Dioxide, Biosensing Techniques, Compartment Syndrome of Leg
- Keywords
- Ischemia, Biosensor, Carbon dioxide, Orthopedic surgery, Limb, Acute compartment syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Sensocure AS
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IscAlert sensor in patient with risk of acute compartment syndrome | – | Device: IscAlert sensor(s) in patient with risk of acute compartment syndromePatients 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IscAlert sensor(s) in patient with risk of acute compartment syndromeof the replanted extremity Insertion of a CO2- and temperature sensor(s) (IscAlert) in the anterior compartment of a lower limb (leg) | Device | IscAlert sensor in patient with risk of acute compartment syndrome |
Primary outcome
Tissue CO2-level
Time frame: 10 days
Tissue CO2-level (kPa) during insertion period
32 secondary outcomes
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
Number of sensory deficit conditions
Time frame: 1 year
Number of paralysis conditions
Time frame: 1 year
Number of rhabdomyolysis conditions
Time frame: 1 year
Number of limb muscle contractures
Time frame: 1 year
Number of acute compartment syndrome conditions during hospitalisation
Time frame: 30 days
Number of acute compartment syndrome conditions after 1 year
Time frame: 1 year
Incidence of death 1 year
Time frame: 1 year
Incidence of death during hospitalisation
Time frame: 30 days
Lenght of stay during primary hospitalisation
Time frame: 30 days
Number of pack-years
Time frame: 30 days
Intravenous fluid
Time frame: 12 hours
Vasoactive drugs
Time frame: 12 hours
Tissue temperature level
Time frame: 10 days
IscAlert functionality
Time frame: 10 days
Intracompartmental pressure
Time frame: 10 days
Systolic blood pressure during hospitalisation
Time frame: 10 days
Diastolic blood pressure during hospitalisation
Time frame: 10 days
Peripheral pulse during hospitalisation
Time frame: 10 days
Hemoglobin
Time frame: 10 days
Creatine kinase
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No. No plan to share IPD to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Clarke-Jenssen, MD, PhD. principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia Limb and Blood Circulation Disorder, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Clarke-Jenssen, MD, PhD. (23027447 ext. +47, uxclaj@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue CO2-level (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.