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

CompletedOBSERVATIONAL
Enrollment

16

Participants

Timeline

Start Date

August 18, 2020

Primary Completion Date

August 21, 2020

Study Completion Date

August 21, 2020

Conditions
HypoxiaDesaturation of Blood
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

Trial Locations (1)

80027

Clinimark, Louisville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic - MITG

INDUSTRY