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RDS MultiSense® SpO2 Validation Study

NCT05359328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-19

No results posted yet for this study

Summary

The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to arterial blood samples assessed by measuring carbon monoxide (CO) bound to hemoglobin by CO-Oximetry. Additionally, data will be collected for heart rate accuracy as compared to reference ECG. The end goal is to provide supporting documentation for the SpO2 and heart rate accuracy validation for RDS MultiSense® Pulse Oximetry.

A minimum of 10 healthy adult male and female participants, ranging in age and pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by International Organization for Standardization ISO 80601-2-61:2017: corrected version 2018-02 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels.

The investigational device will be placed on the placed on the thorax of the participants (patch on the upper back and external electrode on the right pectoral) per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.

Conditions

Interventions

DEVICE

Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line

Measurement of physiological parameters

Sponsors & Collaborators

  • Rhythm Diagnostic Systems

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2022-04-29
Completion
2022-04-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05359328 on ClinicalTrials.gov