N/A
N=18
Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (RD DCI)
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03124797 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Accuracy of Sensor by Arms Calculation — 1.9 % of oxygen saturated hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RD DCI Sensor (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor by Arms Calculation |
1.9 | — |
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 45 for each series of tests.
- Must weigh a minimum of 110 pounds and no more than 250 pounds unless subject is over 6 feet tall.
- Subjects must understand and consent to be in the study.
- American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all).
- Subjects with hemoglobin greater than or equal to 11 g/dL.
Exclusion Criteria
- Subjects with polished, gel or acrylic nails.
- Subjects with damaged and/or finger nail deformities.
- Subjects who have had caffeine consumption the day of the study.
- Subjects who have taken pain medication 24 hours before the study.
- Subjects who have any systemic disease at all.
- Subjects who do not understand the study and the risks.
- Subjects who smoke.
- Subjects who use recreational drugs.
- Subjects who are pregnant or nursing.
- Subjects having either signs or history of peripheral ischemia.
- Subjects with open wounds, lacerations, inflamed tattoos or piercings, visible healing wounds.
- Subjects with psychiatric conditions or are on psychiatric medications.
- Subjects who have had invasive surgery within the past year- including but not limited to major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, Urinary tract surgery, plastic surgery, major ENT surgery, joint replacement or gynecological surgeries.
- Subjects who have had minor surgery or conditions in the past two months including but not limited to minor foot surgery (bunion), arthroscopic procedure, blood donation, plasma donation, skin biopsy/ procedures, root canal, fractures, eye surgery, and other minor procedures.
- Subjects that have been on antibiotics had congestion, head colds, flu, ear infection, chest congestion will have a 2 week waiting period from the time of finishing medications or must have no more symptoms.
- Subjects with claustrophobia, or anxiety.
- Subjects who have been in severe car accidents or a similar type of accidents will have a 12 month waiting period, from the time of the accident.
- Subjects who have had a concussion will have a 12 month waiting period, from the time of the concussion.
- Subjects with chronic unresolved asthma, lung disease and respiratory disease.
- Allergies to lidocaine, latex, adhesives, or plastic.
- Subjects with finger deformities or injuries (specific finger will not be used).
- Subjects with heart conditions, diabetes or hypertension.
- Subjects with resting heart rates greater than 85BPM or below 45BPM
- Subjects who have given birth naturally will have 6 month waiting period. Subjects who had a pregnancy terminated, a miscarriage or had a c-section will have a 12 month waiting period.
- Others deemed ineligible by the clinical staff.
Data sourced from ClinicalTrials.gov (NCT03124797). 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.