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SpO2 Accuracy In Vivo Testing for Neonates & Infants

NCT03843489 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-08-28

No results posted yet for this study

Summary

The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of various pulse oximetry systems and sensors (new designs and/or reprocessed) during non-motion conditions as compared to arterial blood samples, drawn in the normal course of patient care, assessed by CO-Oximetry in neonates and infants. The primary end goal is to provide supporting documentation for the SpO2 accuracy of these pulse oximetry systems. The secondary end goal is to provide data for evaluation of clinical impact of measured to calculated SaO2 and related issues.

Conditions

  • Pulse Oximetry

Interventions

DEVICE

MEDLINE RENEWAL PULSE OXIMETRY SENSORS

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.

DEVICE

Reference CO-oximetry sensor

A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Medline Industries

    lead INDUSTRY

Principal Investigators

  • Robin Deterding, MD · Children's Hospital Colorado

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2021-09-20
Completion
2021-09-20
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03843489 on ClinicalTrials.gov