HealthyNCT03124602
SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor
A study testing Red Diamond Disposable Pulse Oximeter 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 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Red Diamond Disposable Pulse Oximeter Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2017to 11 May 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 non-smoking (smokers including e-cigarette users) adults between the ages of 18 and 50 years of age.
- We may also be interested in specifically recruiting smokers for some portions of this study as well as non-smokers for other portions of this study.
- Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
- BMI less than or equal to 35
- Must have a hemoglobin value greater than or equal to 11 g/dL.
- Baseline heart rate 45 bpm to 85 bpm.
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- CO value less than or equal to 2.0% FCOHb (unless we are specifically interested in recruiting smokers)
- Physical status of ASA I or II (American Society of Anesthesiology Class 1; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease)
- Blood Pressure (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
- Has signed written informed consent
- Female, non-pregnant.
- Female subjects will be provided with a pregnancy test free of charge.
Who cannot join
- Subjects who do not understand the study and the risks involved.
- Subjects with open wounds, lacerations, inflamed tattoos or piercings, visible healing wounds.
- Subjects with frequent or severe headaches and/or migraine headaches.
- Subject has known drug or alcohol abuse. Subjects who uses recreational drugs.
- Subject has experienced a head injury with loss of consciousness within the last year.
- Any chronic bleeding disorders (i.e. hemophilia)
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- Any history of a stroke, myocardial infarction, seizures or heart attack.
- 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 subjects' level of consciousness.
- Known or concurrent chronic usage of psychoactive or anticonvulsive drugs. Subjects with psychiatric conditions or are on psychiatric medications (i.e. tricyclic antidepressants, MAO inhibitors, Lithium, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
- Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study, such as Reynauds Syndrome.
- Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome
- Inability to tolerate sitting still or maintain minimal movement for up to 90 minutes.
- For studies involving finger sensors: subjects with polished, gel or acrylic nails, skin abnormalities affecting the fingers or arms (such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection), distinct finger edema, substantial skin breakdown damaged and/or finger nail deformities (specific finger will not be used, unless we are specifically testing sensors in use with nail polish, gel, and /or acrylic nails).
- Subjects who have/are currently taking anticoagulant medication.
- Subjects who have had caffeine consumption the day of the study.
- Subjects who have taken pain medication within 24 hours of start of study. Unless minimal preventative dose recommended for adults (discretion of physician).
- 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 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 and 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; unless upon further medical history questions the physician determines it does not place the subject in any additional harm, increase their risk, or compromise the subjects' safety.
- 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 or respiratory disease.
- Subjects with allergies to lidocaine, latex, adhesives, or plastic.
- Subjects with heart conditions, Diabetes or hypertension.
- Subjects who have given vaginal delivery will have a 6 month waiting period. Subjects who had a pregnancy terminated, a miscarriage or had a C-section will have a 12 month waiting period.
- 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.
- Discretion of investigator/study 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
- Red Diamond Disposable Pulse Oximeter Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Diamond Disposable Pulse Oximeter 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 receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor Receives: Device: Red Diamond Disposable Pulse Oximeter Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Red Diamond Disposable Pulse Oximeter 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 Accuracy root mean square (ARMS) error value. In order to obtain the Arms value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter 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 per subject
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 start7 Mar 2017
- Primary completion11 May 2017
- Study completion11 May 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
- 35 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
- NCT03124602
- Sponsor's protocol ID
- TP18604A_195
- Status last verified
- Aug 2019
- First submitted
- 14 Apr 2017
- Last updated
- 22 Aug 2019
- 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 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Validation of Noninvasive Red Diamond Disposable Pulse Oximeter Sensor
- ClinicalTrials.gov ID
- NCT03124602
- Acronym / sponsor ID
- TP18604A_195
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2017 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 22 Aug 2019
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: Red Diamond Disposable Pulse Oximeter SensorAll subjects are enrolled into the test group and all subjects receive the noninvasive Red Diamond Disposable Pulse Oximeter Sensor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Competent non-smoking (smokers including e-cigarette users) adults between the ages of 18 and 50 years of age.
- We may also be interested in specifically recruiting smokers for some portions of this study as well as non-smokers for other portions of this study.
- Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
- BMI less than or equal to 35
- Must have a hemoglobin value greater than or equal to 11 g/dL.
Key exclusion criteria (32 listed)
- Subjects who do not understand the study and the risks involved.
- Subjects with open wounds, lacerations, inflamed tattoos or piercings, visible healing wounds.
- Subjects with frequent or severe headaches and/or migraine headaches.
- Subject has known drug or alcohol abuse. Subjects who uses recreational drugs.
- Subject has experienced a head injury with loss of consciousness within the last year.
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 |
|---|---|---|
| Red Diamond Disposable Pulse Oximeter SensorNoninvasive Pulse Oximeter Sensor | Device | Test Subject |
Primary outcome
Accuracy of Red Diamond Disposable Pulse Oximeter Sensor by Arms Calculation
Time frame: 1-5 hours per subject
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 Accuracy root mean square (ARMS) error value. In order to obtain the Arms value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter 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 22 Aug 2019.
- 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 Red Diamond Disposable Pulse Oximeter 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 13 inclusion and 32 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 22 Aug 2019. 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 22 Aug 2019). 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 Red Diamond Disposable Pulse Oximeter Sensor by Arms Calculation (time frame: 1-5 hours per subject). 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 22 Aug 2019.