HealthyNCT03678103

Oxygen Reserve Index (ORi) Validation of INVSENSOR00029

A study testing INVSENSOR00029 in people with Healthy, run by Masimo Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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: 57 participants
Where: 1 siteUnited States
Study dates: 29 Aug 2018to 13 Sep 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 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 less than or equal to 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.
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 a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw.
Subject has open wounds, inflamed tattoos or piercings or any visible healing wounds.
Subject experiences frequent or severe headaches and/or migraine headaches.

Show all 33Show fewer

Subject has known drug or alcohol abuse or uses recreational drugs.
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 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.
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 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 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.

United States1 site

Masimo Corporation
Irvine, California, 92618

Other trials in United States

About this study

ORi is a unitless index that could help clinicians with their assessments or 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 groups in NCT03678103
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 INVSENSOR00029 sensor Receives: Device: INVSENSOR00029

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.
Measured: 1-5 hours
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.
Measured: 1-5 hours
Corcordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values
ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.
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.

29 Aug 201813 Sep 2018

First posted19 Sep 2018
Study start29 Aug 2018
Primary completion13 Sep 2018
Study completion13 Sep 2018

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: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03678103
Sponsor's protocol ID: TP-19449
Status last verified: Sep 2021
First submitted: 17 Sep 2018
Last updated: 30 Sep 2021
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oxygen Reserve Index (ORi) Validation of INVSENSOR00029
ClinicalTrials.gov ID: NCT03678103
Acronym / sponsor ID: TP-19449
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 29 Aug 2018 (actual)
Primary completion: 13 Sep 2018 (actual)
Study completion: 13 Sep 2018 (actual)
First posted: 19 Sep 2018 (actual)
Results: Posted 30 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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: 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 less than or equal to 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 (33 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 a history of fainting (vasovagal), blacking out or losing consciousness during or after a blood draw.
Subject has open wounds, inflamed tattoos or piercings or any visible healing wounds.

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	Test Subject

Primary outcome

Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
Time frame: 1-5 hours
ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
Time frame: 1-5 hours
ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.
Corcordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values
Time frame: 1-5 hours
ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.

Results and safety

Results posted to the registry on 30 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Subject	30	26

Primary outcome: Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.

Time frame: 1-5 hours. Number. Unit: percentage of true positives

Measure	Test Subject n = 26
Value	93.63

Primary outcome: Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.

Time frame: 1-5 hours. Number. Unit: percentage of true negatives

Measure	Test Subject n = 26
Value	86.96

Primary outcome: Corcordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values

Time frame: 1-5 hours. Number. Unit: percentage of accuracy

Measure	Test Subject n = 26
Value	90.59

Adverse events

Time frame: 1 to 5 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Subject	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 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 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 33 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 30 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 30 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?

Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. (time frame: 1-5 hours). 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?

On the ClinicalTrials.gov record for NCT03678103.

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 30 Sep 2021.