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 IscAlert™ 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, IscAlert™ 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 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 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.
