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

NCT ID: NCT05087836

Last Updated: 2022-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-03-10

Brief Summary

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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

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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.

Conditions

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Cerebral Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient undergoing cardiac surgery

Each patient will has 2 sets of sensors attached at forehead and temporal area.

Sensor at forehead area

Intervention Type DEVICE

NIRS sensor attached at forehead area.

Sensor at temporal area

Intervention Type DEVICE

NIRS sensor attached at temporal area.

Interventions

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Sensor at forehead area

NIRS sensor attached at forehead area.

Intervention Type DEVICE

Sensor at temporal area

NIRS sensor attached at temporal area.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Thepakorn Sathitkarnmanee

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thepakorn Sathitkarnmanee, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Khon Kaen University, Khon kaen, Thailand

Locations

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Faculty of Medicine, Khon Kaen University

Khon Kaen, , Thailand

Site Status

Countries

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Thailand

References

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

Reference Type RESULT
PMID: 21388077 (View on PubMed)

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.

Reference Type RESULT
PMID: 17179242 (View on PubMed)

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.

Reference Type RESULT
PMID: 22458277 (View on PubMed)

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.

Reference Type RESULT
PMID: 24810757 (View on PubMed)

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.

Reference Type RESULT
PMID: 23267000 (View on PubMed)

Other Identifiers

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HE641311

Identifier Type: -

Identifier Source: org_study_id

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