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

NCT03124784 | Completed Results FDA Device

• 1 other identifier: TR33143-000190A
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• SpO2 ARMS of Sensor Under Motion Conditions

  Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

  1-5 hours

Study Arms (1)

RD Disposable Sensors

EXPERIMENTAL

All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors

Device: RD Disposable Sensors

Interventions

RD Disposable Sensors DEVICE

Noninvasive pulse oximeter sensor

RD Disposable Sensors

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Tala Harake
• Organization: Masimo Corporation

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: January 3, 2017
• Primary Completion: January 20, 2017
• Study Completion: January 20, 2017
• Last Updated: March 23, 2018
• Results First Posted: March 23, 2018

Record last verified: 2018-02

Locations

US (1)