Detection of Cerebral Ischemia With Artificial Intelligence.

Completed

• Conditions: Ischemia, Cerebral; Artery Occlusion; Surgery; Ischemic Stroke; Anesthesia; Artery Carotid Stenosi
• Interventions: Other: No intervention

• Registration Number: NCT03919370
• Lead Sponsor: Linda Block

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-18
• Study Start: 2020-10-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients planned for carotid surgery or trombectomy
• Giving informed consent to participate

Exclusion Criteria

• Patients that do not consent Patients with arrythmia or pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anaesthesia and surgery	No intervention	Patients without preexisting cerebral injury undergoing abdominal surgery and anaesthesia
Reperfusion	No intervention	Patients undergoing cerebral trombectomy.
Cerebral ischemia	No intervention	Patients undergoing planned surgery for carotid stenosis

Primary Outcome Measures

Name	Time	Method
Heart Rate variability	2020-2030	Changes in Heart Rate Variability from baseline.
Biomarkers indicating cerebral ischemia in blood	2020-2030	Changes in levels of biomarkers in blood from baseline. Total tau, neurofilament light chains, glial fibrillary acidic protein, S-100, neuron specific endolas.
Near infrared spectroscopy	2020-2030	Changes in Near Infrared spectroscopy from baseline.
Electroencephalography	2020-2030	Changes in electroencephalography from baseline, more precisely the Power in alpha bands, beta band, delta bands and quotas between these.
Biomarkers indicating cardiac ischemia in blood	2020-2030	Changes in levels of biomarkers in blood from baseline. Troponin T

Trial Locations

Locations (1)

Sahlgrenska University hospital; 🇸🇪 Gothenburg, Sweden