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Desaturation Validation of INVSENSOR00009

NCT03396835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-08-28

Study results available
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Summary

This study is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject's forehead. The values obtained by the INVSENSOR00009 will be compared to the values collected with the adult sensor.Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.

Conditions

  • Healthy

Interventions

DEVICE

INVSENSOR00009

All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.

Sponsors & Collaborators

  • Masimo Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2018-01-16
Completion
2018-01-16
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 NCT03396835 on ClinicalTrials.gov