Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jan 2012
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2012
CompletedFirst Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedResults Posted
Study results publicly available
July 28, 2017
CompletedJuly 28, 2017
June 1, 2017
3 months
April 14, 2017
May 8, 2017
June 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of Sensor by Arms Calculation
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.
1-5 hours
Study Arms (1)
Test Subject
OTHERAll subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Masimo
Irvine, California, 92618, United States
Results Point of Contact
- Title
- Tala Harake
- Organization
- Masimo
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2017
First Posted
April 24, 2017
Study Start
January 18, 2012
Primary Completion
April 10, 2012
Study Completion
April 10, 2012
Last Updated
July 28, 2017
Results First Posted
July 28, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share