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Accuracy Validation of the Cadwell Pulse Oximetry System

NCT02842476 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2016-07-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the SpO2 accuracy and performance of the Cadwell Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the Cadwell Pulse Oximetry System. It is expected that the Accuracy Root Mean Square (Arms) performance of the Cadwell Pulse Oximetry System will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.

Conditions

  • Anoxia

Interventions

DEVICE

Disposable Sensor

Two adhesive based Pulse Oximeter Probes, S0136J-L were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.

DEVICE

Reusable Sensor

Two soft reusable Pulse Oximeter Probes, Model S0080D-S were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.

DEVICE

Control Pulse Oximetry

A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws.

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Cadwell Industries, Inc.

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

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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 NCT02842476 on ClinicalTrials.gov