CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 18 enrolled
Drug / intervention
Arterial line +1 moredevice
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/NCT02247765
NCT02247765Phase 3Completed

Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well Perfused Subjects With the USB Pulse Oximetry Monitor Interface Cable

Medtronic - MITG·interventional·Posted Sep 25, 2014·Updated May 5, 2017

In Brief

A Phase 3 clinical trial evaluating Arterial line and Motion for Healthy and Hypoxia. Completed, enrolled 18 participants across 2 sites.

Detailed Summary

To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 25, 2014
Enrollment StartNov 1, 2014
Primary CompletionNov 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.8 years ago

Interventions

Arterial linedevice

Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601

Motiondevice

The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure.