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SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study

NCT04559763 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2020-10-22

No results posted yet for this study

Summary

SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion conditions under one system configuration.

The purpose of this Non-Randomized, Prospective,Observational study is to conduct a hypoxia study to directly compare a prototype OxySoft pulse oximeter system to arterial oxygen saturation.

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.

OTHER

Introduction of Motion conditions: tapping or rubbing

Standard motions include tapping or rubbing at periodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency will occur at each plateau. Each plateau will have both an interval of tapping and rubbing. Signals are recorded by a validated, computerized data acquisition system (CAS). The device values are sampled once per second and averaged over the time taken to draw the blood sample, taking into account circulation time delays and differences in device response times

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
2020-08-18
Primary Completion
2020-08-21
Completion
2020-08-21
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 NCT04559763 on ClinicalTrials.gov