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 |
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.
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.
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