NCT05087836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

October 9, 2021

Last Update Submit

March 21, 2022

Conditions

Cerebral Ischemia

Keywords

NIRSRegional cerebral oxygen saturationsensorforeheadtemporal

Outcome Measures

Primary Outcomes (1)

  • rScO2

    Regional cerebral oxygen saturation

    intraoperatively

Study Arms (1)

Patient undergoing cardiac surgery

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

Device: Sensor at forehead areaDevice: Sensor at temporal area

Interventions

Sensor at forehead areaDEVICE

NIRS sensor attached at forehead area.

Patient undergoing cardiac surgery
Sensor at temporal areaDEVICE

NIRS sensor attached at temporal area.

Patient undergoing cardiac surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing elective cardiac surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (5)

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

    PMID: 21388077RESULT

  • 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.

    PMID: 17179242RESULT

  • 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.

    PMID: 22458277RESULT

  • 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.

    PMID: 24810757RESULT

  • 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.

    PMID: 23267000RESULT

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Thepakorn Sathitkarnmanee, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 9, 2021

First Posted

October 21, 2021

Study Start

November 1, 2021

Primary Completion

February 28, 2022

Study Completion

March 10, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations

TH(1)