Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029

NCT04079842 | Completed Results

• 1 other identifier: TP-20088
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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)

• 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

• 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 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.

  1 to 5 hours per subject

Study Arms (1)

INVSENSOR00029

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00029 sensor

Device: INVSENSOR00029

Interventions

INVSENSOR00029 DEVICE

Noninvasive pulse oximeter sensor

INVSENSOR00029

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 ≥ 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo Corporation

aalghazi@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: September 3, 2019
• First Posted: September 6, 2019
• Study Start: August 20, 2019
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: October 19, 2022
• Results First Posted: October 19, 2022

Record last verified: 2022-09

Locations

US (1)