HealthyNCT03124823
Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)
A study testing Rainbow DCI Sensor in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rainbow DCI Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2015to 8 Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Rainbow DCI Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rainbow DCI SensorDevice
Noninvasive pulse oximeter sensor
| Study group | Role | What they receive |
|---|---|---|
| Test Subject | Experimental | All subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor Receives: Device: Rainbow DCI Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Sensor by Arms Calculation
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.
Measured: 1-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start28 Aug 2015
- Primary completion8 Sep 2015
- Study completion8 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124823
- Sponsor's protocol ID
- TR29866-TP17699A
- Status last verified
- Jun 2017
- First submitted
- 14 Apr 2017
- Last updated
- 28 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Noninvasive Pulse Oximeter Sensor (Rainbow DCI)
- ClinicalTrials.gov ID
- NCT03124823
- Acronym / sponsor ID
- TR29866-TP17699A
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2015 (actual)
- Primary completion
- 8 Sep 2015 (actual)
- Study completion
- 8 Sep 2015 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 28 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Subject | Experimental | Device: Rainbow DCI SensorAll subjects are enrolled into the test group and all subjects received the Rainbow DCI Sensor |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rainbow DCI SensorNoninvasive pulse oximeter sensor | Device | Test Subject |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rainbow DCI Sensor in people with Healthy, run by Masimo Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Sensor by Arms Calculation (time frame: 1-5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.