Comparative study of Cerebral oxygen saturation using multi-oxygenation probe and other cerebral oximeter

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005859

Enrollment

Registered

2021-02-03

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : - Explain the clinical trial process and time, Provide the safe environment - Recommend the participant to rest on the bed - Computerized program-based Randomization for order of usi

Comparator module, (VP1200 + Votem sensor, Votem, Korea) and Experimental group (O3 regional cerebral oximeter, Masimo, USA - Computerized program-based Randomization for assignment of patching the s

Clinical Trial progress &gt

? Basic hemodynamic monitoring and saving the monitoring data (EKG, Blood pressure, respiratory rate, peripheral pulse oximeter ? After randomization, measurement of level of cerebral oxygen saturatio

Comparator module (O3 regional cerebral oximeter, Masimo, USA), and Experimental group(VP1200 + Votem sensor, Votem, Korea) B) Measure or calculated level of cerebral oxygen saturation using Compara

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy adult (20-45 years old) 2. No comorbidities 3. Agreement with informed consent for participating to the study

Exclusion criteria

Exclusion criteria: 1. Hypertension, diabetes, cerebrovascular disease, cardiac disease, chronic respiratory disease, hemodynamic disease including anemia 2. Patients with skin-color difference that might affect light absorption, such as jaundice 3. Smokers 4. Patients with possible difference between both cerebral hemispheres due to history of head trauma, stroke, carotid artery surgery or cardiac surgery. 5. Pregnant women, patients with skin reaction, foreigners etc.

Design outcomes

Primary

Measure	Time frame
?Evaluating the agreement of levels of cerebral oxygen saturation between comparator group (O3 Regional oximeter module, Masimo, USA) and experimental group (VP1200+Votem sensor, Votem, Korea) Using Bland–Altman plot (95% limit of agreements ± 1.96 standard deviation)	—

Secondary

Measure	Time frame
? Analysis of time-serial differences of levels of cerebral oxygen saturation among comparator group (O3 Regional oximeter module, Masimo, USA) and experimental group (VP1200+Votem sensor, Votem, Korea) Using Repeated measured ANOVA	—

Countries

Korea, Republic of

Contacts

Public Contactyohan shin

Korea University Anam Hospital

Outcome results