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Oxygen Reserve Index (ORi) Validation of INVSENSOR00014

NCT03500341 · Status: TERMINATED · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-09-08

Study results available
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Summary

The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above.) In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. The ORI device measurement is analyzed by comparing it to the PaO2 measurements from blood samples from a laboratory analyzer.

Conditions

  • Healthy

Interventions

DEVICE

INVSENSOR00014

Noninvasive pulse oximeter sensor

Sponsors & Collaborators

  • Masimo Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-21
Primary Completion
2018-08-01
Completion
2018-08-01

Countries

  • United States

Study Locations

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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 NCT03500341 on ClinicalTrials.gov