Oxygen Reserve Index (ORi) Validation of INVSENSOR00025

NCT03628898 | Completed Results

• 1 other identifier: TP-19367
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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.

  1-5 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.

  1-5 hours per subject

• 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.

  1-5 hours per subject

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00025 sensor

Device: INVSENSOR00025

Interventions

INVSENSOR00025 DEVICE

Noninvasive pulse oximeter sensor

Test Subject

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo Corporation

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: July 26, 2018
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: August 27, 2021
• Results First Posted: August 27, 2021

Record last verified: 2021-08

Locations

US (1)