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NCT05087836 Clinical Trial

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

Cerebral Ischemia Clinical Trial

Official title:
Correlation of Regional Cerebral Oxygen Saturation Monitoring by NIRS Between Standard Site vs Alternative Sites of Sensor Position in Adult Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05087836
Other study ID # HE641311
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date March 10, 2022

Study information
Verified date March 2022
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date March 10, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Sensor at forehead area
NIRS sensor attached at forehead area.
• Sensor at temporal area
NIRS sensor attached at temporal area.

Locations
Country Name City State
Thailand Faculty of Medicine, Khon Kaen University Khon Kaen

Sponsors (1)
Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler V. Influence of intraoperative cerebral oximetry monitoring on neurocognitive function after coronary artery bypass surgery: a randomized, prospective study. Eur J Cardiothorac Surg. 20 — View Citation

Moerman A, Wouters P. Near-infrared spectroscopy (NIRS) monitoring in contemporary anesthesia and critical care. Acta Anaesthesiol Belg. 2010;61(4):185-94. Review. — View Citation

Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. — View Citation

Senanayake E, Komber M, Nassef A, Massey N, Cooper G. Effective cerebral protection using near-infrared spectroscopy monitoring with antegrade cerebral perfusion during aortic surgery. J Card Surg. 2012 Mar;27(2):211-6. doi: 10.1111/j.1540-8191.2012.01420 — View Citation

Zheng F, Sheinberg R, Yee MS, Ono M, Zheng Y, Hogue CW. Cerebral near-infrared spectroscopy monitoring and neurologic outcomes in adult cardiac surgery patients: a systematic review. Anesth Analg. 2013 Mar;116(3):663-76. doi: 10.1213/ANE.0b013e318277a255. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary rScO2 Regional cerebral oxygen saturation intraoperatively
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