Correlation of Cerebral Oxygen Saturation Measured From 2... | NCT05087836

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

NCT05087836

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

Mar 23, 2022Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Cerebral Ischemia

Interventions

Sensor at forehead area
Sensor at temporal area

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Actual

Primary Completion Date

Feb 28, 2022Actual

Completion Date

Mar 10, 2022Actual

First Submitted Date

Oct 9, 2021

First Submission Date that Met QC Criteria

Oct 9, 2021

First Posted Date

Oct 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2022

Last Update Posted Date

Mar 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thepakorn Sathitkarnmanee, Associate professor, Khon Kaen UniversityPrincipal Investigator

Lead Sponsor

Khon Kaen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sensor at forehead area	Device	NIRS sensor attached at forehead area.	Patient undergoing cardiac surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rScO2	Regional cerebral oxygen saturation	intraoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing elective cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thepakorn Sathitkarnmanee, MD	Faculty of Medicine, Khon Kaen University, Khon kaen, Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Khon Kaen University		Khon Kaen		40002	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21388077	Result	Moerman A, Wouters P. Near-infrared spectroscopy (NIRS) monitoring in contemporary anesthesia and critical care. Acta Anaesthesiol Belg. 2010;61(4):185-94.
17179242	Result	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.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases