- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03124823
Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)
June 28, 2017 updated by: Masimo Corporation
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92618
- Masimo Corporation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Subject
All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor
|
Noninvasive pulse oximeter sensor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1-5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 28, 2015
Primary Completion (Actual)
September 8, 2015
Study Completion (Actual)
September 8, 2015
Study Registration Dates
First Submitted
April 14, 2017
First Submitted That Met QC Criteria
April 20, 2017
First Posted (Actual)
April 24, 2017
Study Record Updates
Last Update Posted (Actual)
July 28, 2017
Last Update Submitted That Met QC Criteria
June 28, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- TR29866-TP17699A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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