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

• ClinicalTrials.gov Identifier: NCT03124784
• Recruitment Status: Completed
• First Posted: April 24, 2017
• Results First Posted: March 23, 2018
• Last Update Posted: March 23, 2018
• Sponsor: Masimo Corporation
• Information provided by (Responsible Party): Masimo Corporation

Tracking Information

• First Submitted Date: April 14, 2017
• First Posted Date: April 24, 2017
• Results First Submitted Date: January 19, 2018
• Results First Posted Date: March 23, 2018
• Last Update Posted Date: March 23, 2018
• Actual Study Start Date: January 3, 2017
• Actual Primary Completion Date: January 20, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 23, 2018)

SpO2 ARMS of Sensor Under Motion Conditions [ Time Frame: 1-5 hours ]

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.

• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT03124784 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Accuracy of Oxygen Saturation (SpO2) Noninvasive Pulse Oximeter Sensor (RD Disposable) Under Motion Conditions
• Official Title: Not Provided
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Healthy

Intervention

Device: RD Disposable Sensors

Noninvasive pulse oximeter sensor

Study Arms

Experimental: RD Disposable Sensors

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

Intervention: Device: RD Disposable Sensors

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 23, 2018): 27
• Original Enrollment: Not Provided
• Actual Study Completion Date: January 20, 2017
• Actual Primary Completion Date: January 20, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03124784
• Other Study ID Numbers: TR33143-000190A
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Masimo Corporation
• Study Sponsor: Masimo Corporation
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Masimo Corporation
• Verification Date: February 2018