HealthyNCT03125031
Comparison of Noninvasive Hemoglobin Disposable Sensors
A study testing Rainbow adhesive adult/pediatric sensor and Rainbow adhesive adult/neonatal sensor in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rainbow adhesive adult/pediatric sensor and Rainbow adhesive adult/neonatal sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2014to 25 Jul 2014
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- 18-40 years of age
- Weight of at least 110 lbs and less than 250 lbs for subjects under 6 feet tall.
- Physical status of ASA I of II
- Able to read and communicate in English
- Has signed written informed consent
- Female, non pregnant.
Who cannot join
- Age less than 18 yrs and greater than 40 years
- If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful.
- Weight of less than 110 lbs or more than 250 lbs if the subject is less than 6 feet tall.
- Hemoglobin less than 11 g/dL
- ASA physical status of III. IV, V.
- Pregnant
Show all 16Show fewer
- Subject has known drug or alcohol abuse
- 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.
- Systolic BP >140 mmHg or Diastolic BP > 100 mmHg.
- Baseline heart rate < 50 bpm.
- Inability to tolerate sitting still or minimal movement for up to 90 minutes
- Discretion of investigator
Trial locations and contacts
1 site in 1 country.
About this study
In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
- Conditions
- Healthy
- Being tested
- Rainbow adhesive adult/pediatric sensor, Rainbow adhesive adult/neonatal sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rainbow adhesive adult/pediatric sensorDevice
Rainbow adhesive adult/neonatal sensorDevice
| Study group | Role | What they receive |
|---|---|---|
| Group- Sensor 1 | Experimental | All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors. Receives: Device: Rainbow adhesive adult/pediatric sensor |
| Group- Sensor 2 | Experimental | All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors. Receives: Device: Rainbow adhesive adult/neonatal sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Noninvasive Sensors 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. The accuracy results from both sensors will be assessed for equivalence
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 start10 Jul 2014
- Primary completion25 Jul 2014
- Study completion25 Jul 2014
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT03125031
- Sponsor's protocol ID
- TR26947-TP16847A
- 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
- Comparison of Noninvasive Hemoglobin Disposable Sensors
- ClinicalTrials.gov ID
- NCT03125031
- Acronym / sponsor ID
- TR26947-TP16847A
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2014 (actual)
- Primary completion
- 25 Jul 2014 (actual)
- Study completion
- 25 Jul 2014 (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 concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group- Sensor 1 | Experimental | Device: Rainbow adhesive adult/pediatric sensorAll subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors. |
| Group- Sensor 2 | Experimental | Device: Rainbow adhesive adult/neonatal sensorAll subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female
- 18-40 years of age
- Weight of at least 110 lbs and less than 250 lbs for subjects under 6 feet tall.
- Physical status of ASA I of II
- Able to read and communicate in English
Key exclusion criteria (16 listed)
- Age less than 18 yrs and greater than 40 years
- If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful.
- Weight of less than 110 lbs or more than 250 lbs if the subject is less than 6 feet tall.
- Hemoglobin less than 11 g/dL
- ASA physical status of III. IV, V.
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 adhesive adult/pediatric sensor | Device | Group- Sensor 1 |
| Rainbow adhesive adult/neonatal sensor | Device | Group- Sensor 2 |
Primary outcome
Accuracy of Noninvasive Sensors 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. The accuracy results from both sensors will be assessed for equivalence
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.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 adhesive adult/pediatric sensor and Rainbow adhesive adult/neonatal 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 7 inclusion and 16 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 Noninvasive Sensors 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.