CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
INVSENSOR00028device
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/NCT03704636
NCT03704636N/ACompleted

Desaturation Validation of INVSENSOR00028

Masimo Corporation·interventional·Posted Oct 15, 2018·Updated Jul 15, 2021

In Brief

A clinical study evaluating INVSENSOR00028 for Healthy. Completed, enrolled 46 participants across 1 site.

Detailed Summary

This study is designed to measure the trending accuracy of a noninvasive regional oximetry measurement of somatic oxygen saturation. Two large sensors (adult sensors) will be placed on the subject's forehead. Two investigational sensors (INVSENSOR00028) will be placed on the forearm of the volunteer. The values obtained by the INVSENSOR00028 will be compared to the reference value calculated from the arterial and venous blood measurements. Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen saturation is approximately 70%, while blood samples are drawn at prespecified reference points. The subject will then be returned to inhaling room air.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 15, 2018
Enrollment StartSep 25, 2018
Primary CompletionOct 24, 2018
TodayJul 2, 2026
Enrollment to primary: 29 daysPosted 7.7 years ago

Interventions

INVSENSOR00028device

Noninvasive pulse oximeter sensor