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Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)

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ClinicalTrials.gov Identifier: NCT03124979
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the percentage 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.

Condition or disease Intervention/treatment
Healthy Device: LNCS DBI Sensor

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : January 18, 2012
Primary Completion Date : April 10, 2012
Study Completion Date : April 10, 2012
Arms and Interventions

Arm Intervention/treatment
Test Subject
All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
Device: LNCS DBI Sensor
Noninvasive Measurement of SpO2

Outcome Measures

Primary Outcome Measures :
  1. Accuracy of Sensor by Arms Calculation [ Time Frame: 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(Arms) error 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 these 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124979

United States, California
Irvine, California, United States, 92618
Sponsors and Collaborators
Masimo Corporation
More Information

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124979     History of Changes
Other Study ID Numbers: TR22194-TP16113
First Posted: April 24, 2017    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No