Surgery Clinical Trial - Detection of Cerebral Ischemia With Artificial

Status Recruiting

Clinical Trial Summary

In patients undergoing planned surgery for carotid tromendarterendectomy, a non-invasive device that registers heart rate variability is attached. Furthermore a non-invasive device that monitors cerebral oxygenation- near infrared spectroscopy as well as electroencephalography is also attached. At times when surgeons clamps the carotid artery, there will be a moment with controlled cerebral ischemia. This will be registered by the devices. The information obtained will be used to teach artificial intelligence what patterns are related to cerebral ischemia. The same procedure will be performed in patients undergoing ocklusive cerebral trombectomy, so the artificial intelligence will learn to recognize cerebral reperfusion.Blood samples will be drawn before and after cerebral ischemia may occur and will be analyzed for neurobiomarkers and cardiac biomarkers. To teach the algorithm patterns from anaesthesia and surgery in patients without pre existing neuronal injury, the same method will be applied to patients undergoing mixed abdominal surgery. This group will provide a better knowledge of neuro biomarker patterns during anesthesia and surgery.

Clinical Trial Description

The neurobiomarkers that will be analyzed for detection of cerebral ischemia is Glial Fibrillary Acidic Protein, Neurofilament light chains, S-100B, Neuron specific endolas, Total-tau. Cardiac biomarkers are troponin-t and NT-pro brain natriuretic peptide. Blood sampling will occur before anesthesia induction and 2 and 24 hours after surgery or plausible ischemia for patients undergoing surgery for carotid endarterectomy. For patients undergoing acute thrombectomy blood sampling will be performed as soon as possible after the patient has arrived to the hospital as well as 2 hours and 24 hours later. For patients undergoing mixed abdominal surgery, sampling will be done before anesthesia induction and 2 hours and 24 hours after surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03919370
Study type	Observational
Source	Göteborg University
Contact	Linda Block, PhD
Phone	+46313428173
Email	linda.block@vgregion.se
Status	Recruiting
Phase
Start date	October 1, 2020
Completion date	December 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Detection of Cerebral Ischemia With Artificial Intelligence. — CIDAI-BAS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms