Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: LNCS ADTX Sensor

• Registration Number: NCT03125018
• Lead Sponsor: Masimo Corporation

Brief Summary

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-30
• Primary Completion: 2014-10-09
• Study Completion: 2014-10-09
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-24
• Results First Submitted: 2017-05-08
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-28
• Last Update Submitted: 2017-06-28
• Results First Posted: 2017-07-28
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Competent non-smoking adults between the ages of 18 and 40 for each series of tests.
• Subjects must understand and consent to be in the study.
• American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).

Exclusion Criteria

• Subjects who have any systemic disease at all.
• Subjects who do not understand the study and the risks.
• Smokers.
• Subjects who are pregnant.
• Subjects having either signs or history of peripheral ischemia.
• Others deemed ineligible by the clinical staff.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Subject	LNCS ADTX Sensor	All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.

Primary Outcome Measures

Name	Time	Method
Accuracy of Sensor by Arms Calculation	1-5 hours	Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Trial Locations

Locations (1)

Masimo Corporation; 🇺🇸 Irvine, California, United States