Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry

Not Applicable

Completed

• Conditions: Arterial Disease
• Interventions: Device: Accuracy of the VitalDetect™ pulse oximetry system

• Registration Number: NCT04285411
• Lead Sponsor: Vital USA, Inc.

Brief 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

Detailed Description

An SpO2 accuracy comparison was conducted as part of the final validation of the VitalDetect™ pulse oximetry system. The study was conducted in accordance to Code of Federal Regulations (CFR) for Non-Significant Risk (NSR) investigational studies, following International Standards Organization (ISO) 14155:2011 as appropriate and the pulse oximetry guidelines of ISO 80601-2-61:2017 applicable sections, and Pulse Oximeters - Premarket Notifications Submissions \[510(k)s\] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013).

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.

A secondary goal was to evaluate the pulse rate performance simultaneously collected over the SpO2 range covered. The Pulse Rate Accuracy Root Mean Square (Arms) performance of the VitalDetect™ pulse oximetry system, were expected to meet a specification of 3 bpm.

Study Timeline

• Study Start: 2019-11-04
• Primary Completion: 2019-11-05
• Study Completion: 2019-11-20
• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2020-02-23
• Study First Posted: 2020-02-26
• Results First Submitted: 2020-03-10
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-20
• Last Update Submitted: 2020-05-20
• Results First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARMS SpO2 70-100%	Accuracy of the VitalDetect™ pulse oximetry system	Comparison to Reference CO-Oximetry

Primary Outcome Measures

Name	Time	Method
Evaluate SpO2 Accuracy Per Standards for Pulse Oximetry.	90 Seconds	This study was a comparative, single-center, non-randomized study conducted to evaluate the SpO2 accuracy per standards and guidelines identified above for SpO2 accuracy for pulse oximetry equipment over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison. As a secondary goal, the pulse rate accuracy was compared to ECG Heart Rate realized over the range throughout the hypoxia procedure. Testing was conducted under normal office environment conditions.

Secondary Outcome Measures

Name	Time	Method
The Pulse Rate Accuracy Compared to ECG Heart Rate.	90 Seconds	The pulse rate accuracy was compared to ECG Heart Rate as recorded by the S5 Multi-parameter monitor. Passing criteria was an ARMS of 3 bpm or better based measurements observed during the pulse oximetry evaluation.

Trial Locations

Locations (1)

Clinimark Laboratory Services; 🇺🇸 Louisville, Colorado, United States