Brain Oximeter Calibration and Validation Study
NCT05397704 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2023-08-02
Summary
The purpose of the study is to calibrate and to validate the accuracy of the oximeter with an estimate of brain oxygen levels assessed by measuring arterial and internal jugular vein blood oxygen saturations.
Conditions
- Brain Injuries, Traumatic
Interventions
- DEVICE
-
brain pulse oximeter
brain oxygen monitoring during hypoxia
Sponsors & Collaborators
- collaborator OTHER
-
Cyban Pty Ltd
lead INDUSTRY
Principal Investigators
-
David MacLeod, MBBS · Duke University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-10
- Primary Completion
- 2022-11-05
- Completion
- 2022-11-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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