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Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)

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ClinicalTrials.gov Identifier: NCT03124823
Recruitment Status : Completed
First Posted : April 24, 2017
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Tracking Information
First Submitted Date  ICMJE April 14, 2017
First Posted Date  ICMJE April 24, 2017
Results First Submitted Date  ICMJE May 8, 2017
Results First Posted Date  ICMJE July 28, 2017
Last Update Posted Date July 28, 2017
Actual Study Start Date  ICMJE August 28, 2015
Actual Primary Completion Date September 8, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
Accuracy of Sensor by Arms Calculation [ 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(Arms) error 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  ICMJE
 (submitted: April 20, 2017)
SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor [ 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(Arms) error value.
Change History Complete list of historical versions of study NCT03124823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)
Official Title  ICMJE 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 will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Device: Rainbow DCI Sensor
Noninvasive pulse oximeter sensor
Study Arms  ICMJE Experimental: Test Subject
All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
Intervention: Device: Rainbow DCI Sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2017)
11
Original Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
14
Actual Study Completion Date  ICMJE September 8, 2015
Actual Primary Completion Date September 8, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Competent non-smoking adults between the ages of 18 and 45 for each series of tests.
  • 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 ENT surgery, joint replacement or gynological 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 85BPM or below 45BPM
  • 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03124823
Other Study ID Numbers  ICMJE TR29866-TP17699A
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  ICMJE Not Provided
Responsible Party Masimo Corporation
Study Sponsor  ICMJE Masimo Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Masimo Corporation
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP