Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-06-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)

NCT03125018

Healthy

COMPLETED NA

Accuracy of the O2 MedTech PMS-3000 Monitor

NCT01418079

Healthy

COMPLETED PHASE2

Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions

NCT03124784

Healthy

COMPLETED NA

Validation of Brain Oxygenation Monitor

NCT00815490

Healthy

COMPLETED NA

Accuracy of Noninvasive Pulse Oximeter Sensor (MightySat RX)

NCT03125135

Healthy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oxygen Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Adult Volunteers

Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived tissue oxygen saturation (rSO2) readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.

Group Type EXPERIMENTAL

Masimo O3 Regional Oximeter

Intervention Type DEVICE

Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Masimo O3 Regional Oximeter

Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age between 18 and 45 years, inclusive
* Willing and able to provide written informed consent
* Healthy subjects

Exclusion Criteria

* Pregnant women
* Presence of any cardiovascular or pulmonary disease
* Exposure to high altitude(s) (\>2000 m) within 30 days prior to the study
* Known allergy to intravenous contrast medium or heparin
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
* Patients deemed not suitable for the study at the discretion of the Investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes