Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00025

Masimo Corporation1 site in 1 country29 target enrollmentAugust 19, 2019

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 19, 2019

End Date

August 28, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Masimo Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 ≥ 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.
•Blood Pressure: (Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 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.

Exclusion Criteria

•(\*= Per physician discretion)
•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.\*
•Subject has known drug or alcohol abuse or uses recreational drugs.
•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.

Outcomes

Primary Outcomes

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.

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.

Specificity 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.