HealthyNCT03273166
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
A study testing INVSENSOR00001 and Hemodilution in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of the measured hemoglobin values against reference values obtained by a laboratory hematology analyzer. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- INVSENSOR00001 and Hemodilution
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to 18 Sep 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Competent adults between the ages of 18 and 50 years of age
- Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall
- BMI ≤ 35 unless the physician determines that a higher BMI is not due to morbid obesity, to safeguard subject safety during hemodilution
- Must have a hemoglobin value ≥ 11 g/dL at time of screening, to safeguard subject safety during hemodilution
- Baseline heart rate between 45 bpm and 85 bpm
- CO value less than 2.0% FCOHb
Show all 9Show fewer
- Physical status of ASA I or II (American Society of Anesthesiology Class I; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease) The ASA definition strictly applies to the systemic disease portion of the classification
- Systolic BP less than or equal to 140 mmHg and Diastolic BP less than or equal to 90 mmHg
- Able to read and communicate in English
Who cannot join
- Pregnancy or positive hCG test
- Smokers (including e-cigarette users)
- Subject has known drug or alcohol abuse. Subjects who uses recreational drugs
- Subject has experienced a concussion or head injury with loss of consciousness within the last year
- Any chronic bleeding disorders (i.e. hemophilia)
- Any history of a stroke, myocardial infarction, or seizures
Show all 25Show fewer
- Any cancer or history of cancer (not including skin cancer)
- Chronic neurological diseases (i.e. multiple sclerosis, Huntington's Disease)
- Any cardiac dysrhythmias (i.e. atrial fibrillation)(without physicians clearance)
- Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subject's level of consciousness
- Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome
- Subjects who have/are currently taking anticoagulant medication
- Subjects who have taken opioid pain medication within 24 hours of start of study
- Subjects who do not understand the study and the risks
- Subjects having either signs or history of peripheral ischemia
- 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 gynecological surgeries, heart surgery or thoracic surgery
- Subjects that have symptoms of congestion, head colds, flu, or other illnesses
- Subjects with claustrophobia, or generalized anxiety disorder
- Subjects who have been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months
- Subjects with chronic unresolved asthma, lung disease and respiratory disease
- Subjects with allergies to lidocaine, latex, adhesives, or plastic
- Subjects with heart conditions, insulin-dependent diabetes or uncontrolled hypertension
- Subjects who have given vaginal delivery, had a pregnancy terminated, a miscarriage with hospitalization or had a c-section within the last 6 months
- Subjects who intend on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw and/or arterial line placement
- Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator)
Trial locations and contacts
1 site in 1 country.
About this study
This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of the measured hemoglobin values against reference values obtained by a laboratory hematology analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced by administering intravenous fluids to the volunteer in a controlled manner.
- Conditions
- Healthy
- Being tested
- INVSENSOR00001, Control SpHb sensor, Hemodilution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVSENSOR00001Device
This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.
Control SpHb sensorDevice
This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.
HemodilutionProcedure or surgery
This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure.
| Study group | Role | What they receive |
|---|---|---|
| INVSENSOR00001 sensor | Experimental | This is a nonrandomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers. Receives: Device: INVSENSOR00001; Device: Control SpHb sensor; Procedure: Hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation
Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) 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 posted6 Sep 2017
- Study start29 Aug 2017
- Primary completion18 Sep 2017
- Study completion18 Sep 2017
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
- 82 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
- NCT03273166
- Sponsor's protocol ID
- TP-18788
- Status last verified
- Oct 2020
- First submitted
- 1 Sep 2017
- Last updated
- 26 Oct 2020
- 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 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
- ClinicalTrials.gov ID
- NCT03273166
- Acronym / sponsor ID
- TP-18788
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Posted 26 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution procedure. The sensors' performance will be assessed by comparison of the measured hemoglobin values against reference values obtained by a laboratory hematology analyzer. Blood samples will be collected from healthy volunteers who undergo a hemodilution procedure wherein blood is repeatedly sampled as the concentration of hemoglobin is reduced by administering intravenous fluids to the volunteer in a controlled manner.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INVSENSOR00001 sensor | Experimental | Device: INVSENSOR00001, Device: Control SpHb sensor, Procedure: HemodilutionThis is a nonrandomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Competent adults between the ages of 18 and 50 years of age
- Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall
- BMI ≤ 35 unless the physician determines that a higher BMI is not due to morbid obesity, to safeguard subject safety during hemodilution
- Must have a hemoglobin value ≥ 11 g/dL at time of screening, to safeguard subject safety during hemodilution
- Baseline heart rate between 45 bpm and 85 bpm
Key exclusion criteria (25 listed)
- Pregnancy or positive hCG test
- Smokers (including e-cigarette users)
- Subject has known drug or alcohol abuse. Subjects who uses recreational drugs
- Subject has experienced a concussion or head injury with loss of consciousness within the last year
- Any chronic bleeding disorders (i.e. hemophilia)
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 |
|---|---|---|
| INVSENSOR00001This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers. | Device | INVSENSOR00001 sensor |
| Control SpHb sensorThis is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers. | Device | INVSENSOR00001 sensor |
| HemodilutionThis is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure. | Procedure or surgery | INVSENSOR00001 sensor |
Primary outcome
Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation
Time frame: 1-5 hours
Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- 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 INVSENSOR00001 and Hemodilution 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 9 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 26 Oct 2020. 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 26 Oct 2020). 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?
Comparison of INVSENSOR00001 and Control SpHb 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 26 Oct 2020.