CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
INVSENSOR00025device
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/NCT03628898
NCT03628898N/ACompleted
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Oxygen Reserve Index (ORi) Validation of INVSENSOR00025

Masimo Corporation·interventional·Posted Aug 14, 2018·Updated Aug 27, 2021

In Brief

A clinical study evaluating INVSENSOR00025 for Healthy. Completed, enrolled 47 participants across 1 site.

Detailed Summary

ORi is a unitless index that could help clinicians with their assessments or 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
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartJul 26, 2018
Primary CompletionAug 9, 2018
TodayJul 2, 2026
Enrollment to primary: 13 daysPosted 7.9 years ago

Interventions

INVSENSOR00025device

Noninvasive pulse oximeter sensor