Oxygen Reserve Index (ORi) Validation of INVSENSOR00025
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Masimo Corporation
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
- Status
- Completed
- Last Updated
- 4 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 is greater than or equal to 45 bpm and less than or equal to 85 bpm.
- •Carbon monoxide(CO) value is 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 is less than or equal to 140 mmHg and Diastolic Blood Pressure is less than or equal to 90 mmHg.
- •Subject is able to read and communicate in English and understands the study and risks involved.
Exclusion Criteria
- •Subject is pregnant.
- •Subject smokes (smoking includes e-cigarette use)
- •Subject has a BMI greater than 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.
- •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).
Outcomes
Primary Outcomes
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.
Sensitivity 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.
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.