HealthyNCT03124758
Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)
A study testing Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP)) in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2010to 31 Oct 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight of more than 110 lbs and less than 220 lbs.
- Physical status of ASA I of II
- Able to read and communicate in English
- Has signed written informed consent
- Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.
- -Subjects must understand and consent to be in the study.
Who cannot join
- Age less than 18 yrs and greater than 35 years
- Weight of less than 110 lbs or more than 220 lbs.
- Hemoglobin less than 12 g/dL
- ASA physical status of III. IV, V.
- Pregnant
- Subject has known drug or alcohol abuse
Show all 19Show fewer
- Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
- Subject has experienced a head injury with loss of consciousness within the last year
- Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness
- Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
- Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
- Hypertension: Systolic BP >140 mmHg or Diastolic BP > 90 mmHg.
- Baseline heart rate < 50 bpm.
- Inability to tolerate sitting still or minimal movement for up to 90 minutes
- Discretion of investigator
- Blood Draw Test Procedure
- Subjects less than 18 years of age.
- Subjects who do not understand the study and the risks involved.
- Anyone deemed ineligible by test personnel.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.
- Conditions
- Healthy
- Being tested
- Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))Device
Measurement of Noninvasive Hemoglobin (SpHb)
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Hemoglobin Sensor | Experimental | All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP) Receives: Device: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP)) |
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 hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(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 start20 Apr 2010
- Primary completion31 Oct 2011
- Study completion31 Oct 2011
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
- 354 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
- NCT03124758
- Sponsor's protocol ID
- TR24577-TP15879-TP14065
- Status last verified
- Jun 2017
- First submitted
- 14 Apr 2017
- Last updated
- 27 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 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)
- ClinicalTrials.gov ID
- NCT03124758
- Acronym / sponsor ID
- TR24577-TP15879-TP14065
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2010 (actual)
- Primary completion
- 31 Oct 2011 (actual)
- Study completion
- 31 Oct 2011 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 6 Jun 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 accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory hematology analyzer. Blood samples are collected from healthy volunteers who are enrolled in either a blood draw procedure or a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced in a controlled manner by administering fluids intravenously.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Hemoglobin Sensor | Experimental | Device: Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Weight of more than 110 lbs and less than 220 lbs.
- Physical status of ASA I of II
- Able to read and communicate in English
- Has signed written informed consent
- Female, non pregnant. Female subjects will be provided with a pregnancy test free of charge.
Key exclusion criteria (19 listed)
- Age less than 18 yrs and greater than 35 years
- Weight of less than 110 lbs or more than 220 lbs.
- Hemoglobin less than 12 g/dL
- ASA physical status of III. IV, V.
- Pregnant
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 |
|---|---|---|
| Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))Measurement of Noninvasive Hemoglobin (SpHb) | Device | Noninvasive Hemoglobin Sensor |
Primary outcome
Accuracy of Sensor by Arms Calculation
Time frame: 1-5 hours
Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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 Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP)) 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 6 inclusion and 19 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 27 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 6 Jun 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 27 Jul 2017.