Clinical trial NCT05087836: Correlation of Cerebral Oxygen Saturation Measured From 2 Sensor Sites: Forehead vs. Temporal
Official title: Correlation of Regional Cerebral Oxygen Saturation Monitoring by NIRS Between Standard Site vs Alternative Sites of Sensor Position in Adult Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Ischemia
Keywords: NIRS
Regional cerebral oxygen saturation
sensor
forehead
temporal
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective cardiac surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: rScO2
timeFrame: intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Faculty of Medicine, Khon Kaen University, Khon kaen, Thailand
name: Thepakorn Sathitkarnmanee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moerman A, Wouters P. Near-infrared spectroscopy (NIRS) monitoring in contemporary anesthesia and critical care. Acta Anaesthesiol Belg. 2010;61(4):185-94.
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. doi: 10.1213/01.ane.0000246814.29362.f4.
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.x.
citation: 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. 2015 Mar;47(3):447-54. doi: 10.1093/ejcts/ezu193. Epub 2014 May 7.
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. Epub 2012 Dec 24.