CClinicalTrials.gg
CompletedNCT05087836Updated Mar 23, 2022

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

An observational study in Cerebral Ischemia, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-23.

Sponsored by Khon Kaen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
21
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebral Ischemia

Keywords

  • NIRS
  • Regional cerebral oxygen saturation
  • sensor
  • forehead
  • temporal
03

In context

Brain Ischemia

353 studies on the registry are indexed under Brain Ischemia; 69 are open to participants now.

This study's enrollment of 21 is below the median of 101 across 126 observational studies indexed under Brain Ischemia.

Browse Brain Ischemia studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing elective cardiac surgery

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • history of intracranial or carotid vascular disease
  • previous surgery at face or brain
  • abnormal anatomy of face
  • re-do surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
21 participants (actual)
Patient registry
No

Groups and cohorts

  • Patient undergoing cardiac surgery

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

    Device: Sensor at forehead area · Device: Sensor at temporal area

Interventions

  • DeviceSensor at forehead area

    NIRS sensor attached at forehead area.

  • DeviceSensor at temporal area

    NIRS sensor attached at temporal area.

06

What researchers measure

Primary outcomes

  1. rScO2

    Regional cerebral oxygen saturation

    Time frame: intraoperatively

07

Study locations

1 site
  • Faculty of Medicine, Khon Kaen University
    Khon Kaen, 40002, Thailand
08

References and documents

Publications

  • Moerman A, Wouters P. Near-infrared spectroscopy (NIRS) monitoring in contemporary anesthesia and critical care. Acta Anaesthesiol Belg. 2010;61(4):185-94. PubMed 21388077 ↗
  • 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. PubMed 17179242 ↗
  • 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. PubMed 22458277 ↗
  • 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. PubMed 24810757 ↗
  • 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. PubMed 23267000 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05087836
Lead sponsor
Khon Kaen University
Responsible party
Thepakorn Sathitkarnmanee (Associate professor, Khon Kaen University) — Principal investigator
First posted
Oct 21, 2021
Start date
Nov 1, 2021
Primary completion
Feb 28, 2022
Completion
Mar 10, 2022
Last update
Mar 23, 2022

Study contacts

Thepakorn Sathitkarnmanee, MD
principal investigator · Faculty of Medicine, Khon Kaen University, Khon kaen, Thailand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion