Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Oxygen Deficiency Clinical Trial

Official title:

A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584788
• Other study ID #: SCHE0001
• Status: Completed
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: June 2, 2021

Study information

• Verified date: May 2022
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Oxygen Deficiency

Intervention

Device:
• Masimo O3 Regional Oximeter
Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.

Locations

Country	Name	City	State
Netherlands	Site 1	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Masimo Corporation	University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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