HealthyNCT03500341
Oxygen Reserve Index (ORi) Validation of INVSENSOR00014
A study testing INVSENSOR00014 in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. 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?
- INVSENSOR00014
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2018to 1 Aug 2018
- 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
- Subject is 18-50 years of age.
- Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
- Hemoglobin value is greater than or equal to 11 g/dL.
- Baseline heart rate greater than or equal to 45 bpm and less than or equal to 85 bpm.
- Carbon monoxide (CO) value less than or equal to 2.0% fractional carboxyhaemoglobin (FCOHb)
- Subject has a physical status of American Society of Anesthesiology Class 1 (ASA I, Healthy subjects without any systemic disease at all.) American Society of Anesthesiology Class 2 (ASA II, subjects with mild systemic disease) as it applies to the systemic disease portion of the classification.
- Systolic Blood Pressure less than or equal to 140 mmHg and Diastolic Blood Pressure less than or equal to 90 mmHg.
- Subject is able to read and communicate in English and understands the study and risks involved.
Who cannot join
- Subject is pregnant.
- Subject smokes (smoking includes e-cigarette use)
- Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
- Subject has open wounds, inflamed tattoos or piercings or any visible healing wounds.
- Subject experiences frequent or severe headaches and/or migraine headaches.
- Subject has known drug or alcohol abuse or uses recreational drugs.
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- Subject has experienced a concussion or head injury with loss of consciousness within the last year.
- Subject has any chronic bleeding disorders (i.e. hemophilia)
- Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
- Subject has any cancer or history of cancer (not including skin cancer).
- Subject has a chronic neurological disease (i.e. multiple sclerosis, Huntington's disease).
- Subject has any cardiac dysrhythmia(s) (i.e. atrial fibrillation) and has not received clearance from their physician to participate.
- Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subjects' level of consciousness.
- 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).
- Subject has Wolff-Parkinson-White Syndrome or Stokes - Adams syndrome.
- Subject who has taken anticoagulant medications within the last 30 days.
- Subject has taken opioid pain medication within 24 hours of start of study.
- Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.
- Subject has 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 ear nose or throat (ENT) surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
- Subject has donated blood within the last 2 weeks.
- Subject has symptoms of congestion, head colds, flu or other illnesses.
- Subject experiences claustrophobia or has generalized anxiety disorder.
- Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months.
- Subject has had a concussion within the past 12 months.
- Subject has chronic unresolved asthma, lung disease or respiratory disease.
- Subject is allergic to lidocaine, latex, adhesives, or plastic.
- Subject has heart conditions, insulin-dependent Diabetes or uncontrolled hypertension.
- Subject has given vaginal delivery, had a pregnancy terminated, a miscarriage with hospitalization, or had a cesarean section (C-section) within the past 6 months.
- Subject intends to participate 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 of the study.
- Discretion of investigator/study staff.
Trial locations and contacts
1 site in 1 country.
About this study
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above.) In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. The ORI device measurement is analyzed by comparing it to the PaO2 measurements from blood samples from a laboratory analyzer.
- Conditions
- Healthy
- Being tested
- INVSENSOR00014
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVSENSOR00014Device
Noninvasive pulse oximeter sensor
| Study group | Role | What they receive |
|---|---|---|
| Test Subject | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor Receives: Device: INVSENSOR00014 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity, Sensitivity, and Concordance for the ORi Measurement System as Compared to PaO2
This study reports ORi specificity, sensitivity and concordance for Masimo's ORi measurement system as compared to PaO2 from blood samples.
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 posted18 Apr 2018
- Study start21 Mar 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Why it stopped: The data from the study showed good trending of Delta ORi and Delta PaO2. The study was stopped before full enrollment as a newer version of ORi was developed.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT03500341
- Sponsor's protocol ID
- TP-19193
- Status last verified
- Aug 2021
- First submitted
- 9 Apr 2018
- Last updated
- 8 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Reserve Index (ORi) Validation of INVSENSOR00014
- ClinicalTrials.gov ID
- NCT03500341
- Acronym / sponsor ID
- TP-19193
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The data from the study showed good trending of Delta ORi and Delta PaO2. The study was stopped before full enrollment as a newer version of ORi was developed.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 8 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above.) In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. The ORI device measurement is analyzed by comparing it to the PaO2 measurements from blood samples from a laboratory 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: INVSENSOR00014All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00014 sensor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is 18-50 years of age.
- Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
- Hemoglobin value is greater than or equal to 11 g/dL.
- Baseline heart rate greater than or equal to 45 bpm and less than or equal to 85 bpm.
- Carbon monoxide (CO) value less than or equal to 2.0% fractional carboxyhaemoglobin (FCOHb)
Key exclusion criteria (30 listed)
- Subject is pregnant.
- Subject smokes (smoking includes e-cigarette use)
- Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
- Subject has open wounds, inflamed tattoos or piercings or any visible healing wounds.
- Subject experiences frequent or severe headaches and/or migraine headaches.
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 |
|---|---|---|
| INVSENSOR00014Noninvasive pulse oximeter sensor | Device | Test Subject |
Primary outcome
Specificity, Sensitivity, and Concordance for the ORi Measurement System as Compared to PaO2
Time frame: 1-5 hours per subject
This study reports ORi specificity, sensitivity and concordance for Masimo's ORi measurement system as compared to PaO2 from blood samples.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- 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 INVSENSOR00014 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 8 inclusion and 30 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: stopped early, as of the sponsor's last update on 8 Sep 2021. 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 8 Sep 2021). 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?
Specificity, Sensitivity, and Concordance for the ORi Measurement System as Compared to PaO2 (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 8 Sep 2021.