Detection of Cerebral Ischemia With Artificial Intelligence.

Surgery Clinical Trial

— CIDAI-BAS  

Official title:

Detection of Cerebral Ischemia With Artificial Intelligence- Biomarkers as Indicators in Controlled Cerebral Ischemia and Reperfusion.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03919370
• Other study ID #: CIDAI-BAS
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Göteborg University
• Contact: Linda Block, PhD
• Phone: +46313428173
• Email: linda.block[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Artery Carotid Stenosi
• Artery Occlusion
• Brain Ischemia
• Carotid Stenosis
• Cerebral Infarction
• Ischemia
• Ischemia, Cerebral
• Ischemic Stroke
• Surgery

Intervention

Other:
• No intervention
there will be NO intervention

Locations

Country	Name	City	State
Sweden	Sahlgrenska University hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Linda Block	Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Block L, El-Merhi A, Liljencrantz J, Naredi S, Staron M, Odenstedt Herges H. Cerebral ischemia detection using artificial intelligence (CIDAI)-A study protocol. Acta Anaesthesiol Scand. 2020 Oct;64(9):1335-1342. doi: 10.1111/aas.13657. Epub 2020 Jul 2. — View Citation

Outcome

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