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Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Primary Purpose

Oxygen Deficiency

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Masimo O3 Regional Oximeter
Sponsored by
Masimo Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oxygen Deficiency

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Site 1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy Adult Volunteers

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 6, 2020
Last Updated
May 31, 2022
Sponsor
Masimo Corporation
Collaborators
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT04584788
Brief Title
Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Official Title
A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
Collaborators
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Deficiency

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Adult Volunteers
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Masimo O3 Regional Oximeter
Intervention Description
Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
Primary Outcome Measure Information:
Title
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2
Description
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).
Time Frame
1 visit up to 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Site 1
City
Groningen
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

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