Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
OBSERVATIONAL
2021-05-14
2021-05-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
New Method for Real-time Detection of Tissue Ischemia (ISCALERT)
NCT04879875
Ischemia Detection During Development of Acute Compartment Syndrome
NCT06079255
I-Gel in Out-of-hospital Cardiac Arrest in Norway
NCT02090218
Critical Limb Ischemia and Transcutaneous Oximetry
NCT04369781
Feasibility of the IC-Flow Device for Fluorescent Perfusion Evaluation During Feasibility of the IC-Flow Device
NCT03860493
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. 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.
2. No clinically significant bleeding or infection will occur using IscAlert in this clinical study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
IscAlert
3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and carbon dioxide is measured continuously.
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.
IscAlert
3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and carbon dioxide is measured continuously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IscAlert
3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and carbon dioxide is measured continuously.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject must be ≥ 18 years
* Able to give written signed informed consent
* Tourniquet planned to be used \> 30 minutes
Exclusion Criteria
* Chronic use of anticoagulants
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Commission
OTHER
Oslo University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Espen Lindholm
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Magne Røkkum, Md, Ph.d
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oslo University Hospital
Oslo, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1-20
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.