Clinical trial NCT03919370: Detection of Cerebral Ischemia With Artificial Intelligence.
Official title: Detection of Cerebral Ischemia With Artificial Intelligence- Biomarkers as Indicators in Controlled Cerebral Ischemia and Reperfusion.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia, Cerebral
Ischemic Stroke
Artery Occlusion
Artery Carotid Stenosi
Anesthesia
Surgery
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2019-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: See above

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate variability
timeFrame: 2020-2030
measure: Near infrared spectroscopy
timeFrame: 2020-2030
measure: Electroencephalography
timeFrame: 2020-2030
measure: Biomarkers indicating cerebral ischemia in blood
timeFrame: 2020-2030
measure: Biomarkers indicating cardiac ischemia in blood
timeFrame: 2020-2030
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University hospital
Study officials:
affiliation: Inst Clin Sciences
name: Linda Block, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.