CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
INVSENSOR00012device
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/NCT03435224
NCT03435224N/ACompleted

Desaturation Validation of INVSENSOR00012

Masimo Corporation·interventional·Posted Feb 15, 2018·Updated Oct 1, 2024

In Brief

A clinical study evaluating INVSENSOR00012 for Healthy. Completed, enrolled 39 participants across 1 site.

Detailed Summary

This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples 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 concentration is approximately 70%. During the desaturation, the subject's hand and arm without the arterial line will be subjected to motion.After completing the desaturation, the gas mixture will be returned to room air concentrations.

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 15, 2018
Enrollment StartJan 17, 2018
Primary CompletionFeb 12, 2018
TodayJul 2, 2026
Enrollment to primary: 25 daysPosted 8.4 years ago

Interventions

INVSENSOR00012device

Noninvasive pulse oximeter sensor