HealthyNCT04079842
Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029
A study testing INVSENSOR00029 in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
ORi is a unitless index 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. 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?
- INVSENSOR00029
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2019to 28 Aug 2019
- 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 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 ≥ 45 bpm and ≤ 85 bpm.
- Carbon monoxide (CO) value ≤ 2.0% fractional carboxyhemoglobin (FCOHb).
- Subject has a 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) as it applies to the systemic disease portion of the classification.
- Blood Pressure: (Systolic Blood Pressure ≤ 140 mmHg and ≥ 90 mmHg, Diastolic Blood Pressure ≤ 90 mmHg and ≥ 50 mmHg), and if blood pressure is lower than 100/60 subject passes an orthostatic blood pressure test
- Subject is able to read and communicate in English and understands the study and risks involved.
Who cannot join
- Subject is pregnant.
- 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 a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.
- Subject smokes one pack of cigarettes or more in one week, and/or the equivalent of e-cigarette liquid, and smokers are not being recruited as indicated in the CSRF.
- Subject has open wounds, inflamed tattoos or piercings and/or any visible healing wounds that a medical professional renders them at an increased risk for participation (per physician discretion).
- Subject has known drug or alcohol abuse or uses recreational drugs.
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- Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
- Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months.
- Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
- Subject who has taken anticoagulant medications within the last 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS).
- Subject has donated blood within the past 4 weeks.
- Subject has any chronic bleeding disorder (i.e. hemophilia)
- Subject has any symptomatic cardiac dysrhythmia (i.e. atrial fibrillation) and has not received clearance from their physician to participate.
- Subject has Wolff-Parkinson-White Syndrome or Stokes - Adams syndrome.
- Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subjects' level of consciousness.
- Subject has taken opioid pain medication within 24 hours of start of study.
- Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).
- Subject is taking medications known to treat any type of infectious disease (per physician discretion).
- 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, appendix, plastic surgery (per physician discretion).
- Subject has had invasive surgery within the past year- including but not limited to gallbladder, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, major ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
- Subject has symptoms of congestion, head cold, flu or other illnesses.
- Subject is claustrophobic and/or has generalized anxiety disorder.
- Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months.
- Subject has any cancer or history of cancer (not including skin cancer), per physician discretion.
- Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease.
- Subject is allergic to lidocaine, latex, adhesives, or plastic.
- Subject has a heart condition, insulin-dependent Diabetes, or uncontrolled hypertension.
- Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the past 6 months.
- Subject intends to participate in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis) 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 that involved an arterial line.
- Subject has any medical condition which in the judgement of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator/study staff).
Trial locations and contacts
1 site in 1 country.
About this study
ORi is a unitless index 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. Changes in ORi values are analyzed by comparing it to corresponding changes in PaO2 measurements from blood samples.
- Conditions
- Healthy
- Being tested
- INVSENSOR00029
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVSENSOR00029Device
Noninvasive pulse oximeter sensor
| Study group | Role | What they receive |
|---|---|---|
| INVSENSOR00029 | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor Receives: Device: INVSENSOR00029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
Measured: 1-5 hours per subject
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
Measured: 1 to 5 hours per subject
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
Measured: 1 to 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 posted6 Sep 2019
- Study start20 Aug 2019
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
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
- 29 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
- NCT04079842
- Sponsor's protocol ID
- TP-20088
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2019
- Last updated
- 19 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029
- ClinicalTrials.gov ID
- NCT04079842
- Acronym / sponsor ID
- TP-20088
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Posted 19 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ORi is a unitless index 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. Changes in ORi values are analyzed by comparing it to corresponding changes in PaO2 measurements from blood samples.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INVSENSOR00029 | Experimental | Device: INVSENSOR00029All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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 ≥ 45 bpm and ≤ 85 bpm.
- Carbon monoxide (CO) value ≤ 2.0% fractional carboxyhemoglobin (FCOHb).
- Subject has a 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) as it applies to the systemic disease portion of the classification.
Key exclusion criteria (31 listed)
- Subject is pregnant.
- 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 a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.
- Subject smokes one pack of cigarettes or more in one week, and/or the equivalent of e-cigarette liquid, and smokers are not being recruited as indicated in the CSRF.
- Subject has open wounds, inflamed tattoos or piercings and/or any visible healing wounds that a medical professional renders them at an increased risk for participation (per physician discretion).
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 |
|---|---|---|
| INVSENSOR00029Noninvasive pulse oximeter sensor | Device | INVSENSOR00029 |
Primary outcome
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values
Time frame: 1-5 hours per subject
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
Time frame: 1 to 5 hours per subject
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
Time frame: 1 to 5 hours per subject
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- 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 INVSENSOR00029 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 31 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 19 Oct 2022. 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 19 Oct 2022). 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?
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values (time frame: 1-5 hours per subject). The study lists 3 primary outcomes in all. 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 19 Oct 2022.