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

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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:
Information provided by (Responsible Party):
Masimo Corporation

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.

Condition or disease Intervention/treatment Phase
Healthy Device: RD Disposable Sensors Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : January 20, 2017

Arm Intervention/treatment
Experimental: RD Disposable Sensors
All subjects are enrolled into the test group and all subjects received the RD Disposable Sensors
Device: RD Disposable Sensors
Noninvasive pulse oximeter sensor




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124784


Locations
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United States, California
Masimo Corporation
Irvine, California, United States, 92618
Sponsors and Collaborators
Masimo Corporation
  Study Documents (Full-Text)

Documents provided by Masimo Corporation:

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Responsible Party: Masimo Corporation
ClinicalTrials.gov Identifier: NCT03124784     History of Changes
Other Study ID Numbers: TR33143-000190A
First Posted: April 24, 2017    Key Record Dates
Results First Posted: March 23, 2018
Last Update Posted: March 23, 2018
Last Verified: February 2018

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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