Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions

Completed · Not applicable

Conditions studied: Healthy

In brief

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 under motion conditions will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

Key facts

Study ID

NCT03124784

Run by

Masimo Corporation

People needed

27

Starts

2017-01-03

Expected to finish

2017-01-20

Last updated by the study team

2018-03-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Competent non-smoking adults
• 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.

You may not qualify if…

• 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 ears, nose throat (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 85 beats per minute (BPM) or below 45 BPM
• 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.

Where it is running

• Masimo Corporation — Irvine, California, United States

Full record on ClinicalTrials.gov

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