Correlation of Cerebral Oxygen Saturation Measured From 2 Sensor Sites: Forehead vs. Temporal

Completed

• Conditions: Cerebral Ischemia
• Interventions: Device: Sensor at forehead area; Device: Sensor at temporal area

• Registration Number: NCT05087836
• Lead Sponsor: Khon Kaen University

Brief Summary

Cardiac surgery and neurosurgery may decrease cerebral blood flow leading to cerebral dysfunction. Regional cerebral oxygen saturation (rScO2) monitor via Near-infrared spectometry (NIRS) is recommended for early detection and correction. The standard site of NIRS sensor is forehead area which is impractical in operation with incision at forehead area. The investigators suggest an alternative sensor site at temporal area. The objective of this study is to assess the correlation of rScO2 measured from sensor attached at forehead vs. temporal area.

Detailed Description

Cardiac surgery and neurosurgery may decrease cerebral blood flow leading to neurologic morbidity, e.g., postoperative stroke, delirium, or postoperative cognitive dysfunction. Regional cerebral oxygen saturation (rScO2) monitor via Near-infrared spectometry (NIRS) is thus recommended for early detection and correction. Murkin et al.(2007) conducted a randomized controlled trial in coronary artery bypass graft (CABG) with NIRS monitoring showed that patients who received intervention to avoid rScO2 \< 75% of baseline had less major organ morbidity including stroke, and mortality. Senanayake et al.(2012) revealed that NIRS could decrease neurologic complication in patients undergoing ascending aortic replacement with moderate hypothermic circulatory arrest.

The standard site of NIRS sensor is forehead area. There are some types of surgery involving incision at forehead area which makes it not possible to attach sensor at this site. The investigators propose an alternative sensor site at temporal area to be used in such situation.

The objective of this study is to assess the correlation of rScO2 measured from sensor attached at forehead vs. temporal area.

Study Timeline

• Study First Submitted: 2021-10-09
• Study First Submitted QC: 2021-10-09
• Study First Posted: 2021-10-21
• Study Start: 2021-11-01
• Primary Completion: 2022-02-28
• Status Verified: 2022-03
• Study Completion: 2022-03-10
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• age =/> 18 y
• undergoing elective cardiac surgery
• American Society of Anesthesiologists (ASA) classification II-III

Exclusion Criteria

• history of intracranial or carotid vascular disease
• previous surgery at face or brain
• abnormal anatomy of face
• re-do surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient undergoing cardiac surgery	Sensor at temporal area	Each patient will has 2 sets of sensors attached at forehead and temporal area.
Patient undergoing cardiac surgery	Sensor at forehead area	Each patient will has 2 sets of sensors attached at forehead and temporal area.

Primary Outcome Measures

Name	Time	Method
rScO2	intraoperatively	Regional cerebral oxygen saturation

Trial Locations

Locations (1)

Faculty of Medicine, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand