CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
INVSENSOR00029device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04079842
NCT04079842N/ACompleted
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Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029

Masimo Corporation·interventional·Posted Sep 6, 2019·Updated Oct 19, 2022

In Brief

A clinical study evaluating INVSENSOR00029 for Healthy. Completed, enrolled 29 participants across 1 site.

Detailed Summary

ORi is a unitless index 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. Changes in ORi values are analyzed by comparing it to corresponding changes in PaO2 measurements from blood samples.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 6, 2019
Enrollment StartAug 20, 2019
Primary CompletionAug 28, 2019
TodayJul 2, 2026
Enrollment to primary: 8 daysPosted 6.8 years ago

Interventions

INVSENSOR00029device

Noninvasive pulse oximeter sensor