Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

NCT04584788 | Completed Results FDA Device

• 1 other identifier: SCHE0001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oxygen Deficiency

Outcome Measures

Primary Outcomes (1)

• Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2

  Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).

  1 visit up to 8 hours

Study Arms (1)

Healthy Adult Volunteers

EXPERIMENTAL

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.

Device: Masimo O3 Regional Oximeter

Interventions

Masimo O3 Regional Oximeter DEVICE

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

Healthy Adult Volunteers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masimo Corporation: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

Site 1

Groningen, Netherlands

Location

Related Publications (1)

• De Keijzer IN, Massari D, Niezen CK, Bokkers RPH, Vos JJ, Scheeren TWL. Agreement of somatic and renal near-infrared spectroscopy with reference blood samples during a controlled hypoxia sequence: a healthy volunteer study. J Clin Monit Comput. 2023 Jun;37(3):805-814. doi: 10.1007/s10877-022-00944-9. Epub 2022 Dec 4.

  PMID: 36463540 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Cristina Johnson
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

(949) 297-7576

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: November 30, 2020
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: June 27, 2022
• Results First Posted: June 27, 2022

Record last verified: 2022-05

Locations

NL (1)