- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04893473
New Method for Real-time Detection of Tissue Ischemia (ISCALERT)
New Method for Real-time Detection of Tissue Ischemia; IscAlert™ - Study
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlert™ device in patients scheduled for limb (arm/leg) surgery with tourniquet.
50 number of patients will be enrolled to undergo the procedures detailed in this clinical investigational plan using 250 devices.
IscAlert is 0.8 mm in diameter and in vitro testing, shows stable and accurate measurements of tissue carbon dioxide . More than 100 animal experiments have been done with the sensor. The experiments have shown that the sensor detects ischemia (Increased carbon dioxide-measurements) in real time in the following organs and tissues: Brain, heart, liver, kidneys, pancreas, intestines, musculature and subcutaneous tissue. Sensitivity and specificity are close to 100%. The sensors are inserted into tissue by a split needle technique. The split needle is the size of a 3-gauge peripheral venous catheter. In animal studies, no complications have been detected when using the sensor.
The IscAlert catheters are connected to an electronics unit that is fixed to the skin with an adhesive plaster outside the sterile area. The electrical signals are redirected to a personal computer approved for clinical use which continuously records tissue pressures of carbon dioxide .
IscAlert is inserted into normal muscle and subcutaneous tissue proximal on the limb to be operated. The insertion is distal to the blood cuff, and far away from the surgery field. The insertion is done under sterile conditions in accordance with standard sterility criteria at the hospital. No pain during insertion will occur because of insertion is performed after anesthesia induction. Also, the insertion can be compared to an intramuscular injection.
An identical IscAlert catheter is also inserted in the opposite extremity that is not to be operated and serves as a reference value. After the tourniquet is inflated, ischemia develops in the muscles and subcutaneous tissue. This will result in an increase in carbon dioxide, which will be detected by the sensor on the operated extremity, while the sensor on the non-operated will show normal values.
After releasing the tourniquet cuff, the muscle will be reperfused and the carbon dioxide level is expected to decrease into normal levels within 15 - 45 minutes. In 25 patients, the biosensors will be removed from the patient before the patient is discharged from the operating room, but in 25 of the patients, IscAlert will be inserted for 72 hours in the operated extremity after the end of surgery to identify drifting of the sensors. After this, the sensors are removed.
The primary objective is to evaluate the ability of the IscAlert device to measure carbon dioxide levels in ischemic and non-ischemic limb musculature and subcutaneous tissue in patients who experience orthopedic surgery with limb tourniquet and to assess the safety/efficacy using device IscAlert.
Our hypotheses are:
- The IscAlert device will be able to detect the presence of ischemia in muscle and subcutaneous tissue, whereby carbon dioxide levels, measured by IscAlert, will be higher in ischemic musculature than non-ischemic musculature in patients undergoing orthopedic limb surgery.
- No clinically significant bleeding or infection will occur using IscAlert in this clinical study.
Study Type
Contacts and Locations
Study Locations
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Oslo, Norway, 0424
- Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients must be scheduled for orthopedic limb surgery with planned use of tourniquet.
- Subject must be ≥ 18 years
- Able to give written signed informed consent
- Tourniquet planned to be used > 30 minutes
Exclusion Criteria:
- Sign of inflammation/infection, hematoma, and traumatized tissue at insertion site
- Chronic use of anticoagulants
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Patients scheduled for limb (arm/leg) surgery with tourniquet where IscAlert is removed immediately after surgery. All patients will receive 3 sensors in the limb undergoing surgery and two control sensors in the opposite limb. The sensor in the opposite extremity which is not to be operated serves as a reference value for carbon dioxide. |
3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and carbon dioxide is measured continuously.
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Group 2
Patients scheduled for limb (arm/leg) surgery with tourniquet where IscAlert is removed 72 hours after surgery. All patients will receive 3 sensors in the limb undergoing surgery and two control sensors in the opposite limb. The sensor in the opposite extremity which is not to be operated serves as a reference value for carbon dioxide. |
3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and carbon dioxide is measured continuously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tissue carbon dioxide level
Time Frame: 72 hours
|
Tissue carbon dioxide level (kPa) during insertion period
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72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding
Time Frame: 72 hours
|
Amount of blood from insertion site (ml)
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72 hours
|
Infection
Time Frame: 1 week
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Infection from insertion site at the discretion of the investigator (yes or no)
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1 week
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Arterial carbon dioxide level
Time Frame: 2 hours
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Blood gass analysis of carbon dioxide during surgery (kPa)
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2 hours
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Arterial lactate level
Time Frame: 2 hours
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Blood gass analysis of lactate during surgery (mmol/L)
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2 hours
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Arterial pH level
Time Frame: 2 hours
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Blood gass analysis of pH during surgery
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2 hours
|
Arterial Oxygen level
Time Frame: 2 hours
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Blood gass analysis of Oxygen during surgery (Kpa)
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2 hours
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Time of tourniquet
Time Frame: 2 hours
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Minutes of inflated tourniquet during surgery (minutes)
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2 hours
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End-tidal level of carbon dioxide
Time Frame: 2 hours
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End-tidal level of carbon dioxide during anesthesia (kPa)
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2 hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Magne Røkkum, MD, Ph.D, Oslo University Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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