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

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ClinicalTrials.gov Identifier: NCT03125018
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Device: LNCS ADTX Sensor Not Applicable

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 : September 30, 2014
Actual Primary Completion Date : October 9, 2014
Actual Study Completion Date : October 9, 2014

Arm Intervention/treatment
Experimental: Test Subject
All subjects are enrolled into the test group and receive the LNCS ADTX Sensor.
Device: LNCS ADTX Sensor
Noninvasive pulse oximeter sensor.




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 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.



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

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.

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): NCT03125018


Locations
United States, California
Masimo Corporation
Irvine, California, United States, 92618
Sponsors and Collaborators
Masimo Corporation

Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03125018     History of Changes
Other Study ID Numbers: TR27479-TP16850A
First Posted: April 24, 2017    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: July 28, 2017
Last Verified: June 2017

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