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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:4/17/2018
Start Date:January 3, 2017
End Date:January 20, 2017

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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.


Inclusion Criteria:

- 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.

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
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.
We found this trial at
1
site
Irvine, California 92618
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Irvine, CA
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