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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04879875
Other study ID # 1-21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date July 24, 2022

Study information

Verified date April 2024
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlertâ„¢ device in patients scheduled for limb (arm/leg) surgery with tourniquet. IscAlert is measuring CO2 in muscular and subcutaneous tissue. IscAlert is inserted into normal muscle and subcutaneous tissue in ischemic (operated limb with a tourniquet) and non-ischemic limb (non-operated limb).After the tourniquet is inflated, ischemia develops in the muscles and subcutaneous tissue. This will result in an increase in CO2, which will be detected by the sensors on the operated extremity, while the sensors on the non-operated will show normal values. After releasing the tourniquet cuff, the muscle will be reperfused and the CO2 level is expected to decrease into normal levels. 50 number of patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the operating room, but in 25 of the patients, IscAlertâ„¢ will be inserted for 72 hours in the operated extremity after the end of surgery. After this, the sensors are removed. 250 Devices is planned to be used in this clinical study.


Description:

This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlertâ„¢ 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 pCO2. More than 100 animal experiments have been done with the sensor. The experiments have shown that the sensor detects ischemia (Increased CO2-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 PC approved for clinical use which continuously records tissue pressures of CO2. IscAlert sensors (3 - three) are 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. Two identical IscAlert sensors are 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 CO2, which will be detected by the sensors on the operated extremity, while the sensors on the non-operated will show normal values. After releasing the tourniquet cuff, the muscle will be reperfused and the CO2 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 up to 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 CO2-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 CO2 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 24, 2022
Est. primary completion date July 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
IscAlert
3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and CO2 is measured continously. IscAlert sensors are removed after end of surgery.
IscAlert 72h
3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and CO2 is measured continously. IscAlert sensors are removed 72 hours after end of surgery

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital European Commission

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 periode 72 hours
Secondary Bleeding Amount of blood from insertion site (ml) 72 hours
Secondary Infection Infection from insertion site at the discretion of the investigator (yes or no) 30 days
Secondary Pain score at insertion site - Numerical Rating Scale (NRS) - 30 days after discharge from hospital Pain from insertion site measured by Numeric Rating Scale (NRS; 0-10 points) 30 days
Secondary Pain score at insertion site - Numerical Rating Scale (NRS) - 7 days after discharge from hospital Pain from insertion site measured by Numeric Rating Scale (NRS; 0-10 points) 7 days
Secondary Arterial CO2 level Blood gass analysis of CO2 during surgery (kPa) 3 hours
Secondary Arterial lactate level Blood gass analysis of lactate during surgery (mmol/L) 3 hours
Secondary Arterial pH level Blood gass analysis of pH during surgery 3 hours
Secondary Arterial O2 level Blood gass analysis of O2 during surgery (Kpa) 3 hours
Secondary Time of tourniquet Minutes of inflated tourniquet during surgery (minutes) 180 minutes
Secondary End-tidal level of CO2 End-tidal level of CO2 during anesthesia (kPa) 4 hours
Secondary End-tidal level of CO2 72 hours End-tidal level of CO2 during postoperative recovery (kPa) 72 hours
Secondary Duration of surgery Duration of surgery - Number of minutes 180 minutes
Secondary Duration of anesthesia Duration of anesthesia - Number of minutes 240 minutes
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