Brain Oximeter Calibration and Validation Study

NCT05397704 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-08-02

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397704 on ClinicalTrials.gov