CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Accuracy of the VitalDetect™ pulse oximetry systemdevice
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/NCT04285411
NCT04285411N/ACompleted
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Results of the SpO2 and Pulse Rate Accuracy Comparison of VitalDetect™ to Arterial Blood CO-Oximetry and Reference ECG

Vital USA, Inc.·interventional·Posted Feb 26, 2020·Updated Jun 2, 2020

In Brief

A clinical study evaluating Accuracy of the VitalDetect™ pulse oximetry system for Arterial Disease. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Clinical Investigation Plan: Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry Study ID# PR 2019-353, Version: Rev 1, Date: 15 Oct 2019 Study Dates: November 4-5, 2019

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArterial Disease
CountriesUnited States
CollaboratorsClinimark, LLC

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 26, 2020
Enrollment StartNov 4, 2019
Primary CompletionNov 5, 2019
Study CompletionNov 20, 2019
TodayJul 2, 2026
Enrollment to primary: 1 daysPosted 6.4 years ago

Interventions

Accuracy of the VitalDetect™ pulse oximetry systemdevice

The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.