N/A
N=13
Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX)
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03125018 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Accuracy of Sensor by Arms Calculation — 2.0 % of oxygen saturated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LNCS ADTX Sensor (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor by Arms Calculation |
2.0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03125018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.