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SpO2 Accuracy Low Saturation Validation of the OxySoftN Sensor

NCT04811963 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-05-18

No results posted yet for this study

Summary

To compare prototype pulse oximeter saturation measurements, during normal to low saturation, to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from healthy human subjects.

Conditions

Interventions

DEVICE

Non-Invasive Controlled Hypoxia

Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Arthur Cabrera, MD · Clinimark, LLC

Eligibility

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

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2021-04-09
Completion
2021-04-09
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04811963 on ClinicalTrials.gov