Oxygen Reserve Index Validation for RD Lite Sensors

NCT03128892 | Completed Results

• 1 other identifier: TP18600A-135_197
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Oxygen Reserve Index (ORI) is a parameter that provides information on arterial partial pressure of oxygen (PaO2). In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. The ORI device measurement is analyzed by comparing it to the PaO2 measurements from a laboratory analyzer.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Specificity of ORI to Detect Drops in Oxygenation

  A measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Specificity, as measured in this outcome, is the probability of ORI not dropping when there is no drop in blood oxygen levels (desaturation).

  1-5 hours per subject

• Sensitivity of ORI to Detect Drops in Oxygenation

  A measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Sensitivity, as measured in this outcome, is the probability of ORI dropping when there is a drop in blood oxygenation levels (desaturation).

  1-5 hours

• Concordance of ORI to Detect Drops in Oxygenation

  A measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Concordance, as measured in this outcome, is the probability of ORI to respond accurately to changes (or lack of thereof) in underlying blood oxygenation levels. It is computed as a ratio of true classifications (true positives and true negatives) to the sample size. An ideal detector will have a concordance value of 1 (or 100%).

  1-5 hours

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects are enrolled into the test group and all subjects received the Noninvasive Oxygen Reserve Index - RD Lite Sensors

Device: Oxygen Reserve Index - RD Lite Sensors

Interventions

Oxygen Reserve Index - RD Lite Sensors DEVICE

Test Subject

Eligibility Criteria

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

You may qualify if:

• Competent non-smoking (smokers including e-cigarette users) adults between the ages of 18 and 50 years of age.
• We may also be interested in specifically recruiting smokers for some portions of this study as well as non-smokers for other portions of this study.
• Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
• BMI less than or equal to 35
• Must have a hemoglobin value greater than or equal to 11 g/dL.
• Baseline heart rate \> 45 bpm and \< 85 bpm.
• CO value less than or equal to 2.0% FCOHb (unless we are specifically interested in recruiting smokers)
• 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)
• Blood Pressure (Systolic BP less than for equal to 140 mmHg and Diastolic BP less than or equal to 90 mmHg).
• Able to read and communicate in English
• Has signed written informed consent
• Female, non-pregnant.
• Female subjects will be provided with a pregnancy test free of charge.

You may not qualify if:

• Subjects who do not understand the study and the risks involved.
• Subjects with open wounds, lacerations, inflamed tattoos or piercings, visible healing wounds.
• Subjects with frequent or severe headaches and/or migraine headaches.
• Subject has known drug or alcohol abuse. Subjects who uses recreational drugs.
• Subject has experienced a head injury with loss of consciousness within the last year.
• Any chronic bleeding disorders (i.e. hemophilia)
• Any history of a stroke, myocardial infarction, seizures or heart attack.
• Any cancer or history of cancer (not including skin cancer).
• Chronic neurological diseases (i.e. multiple sclerosis, Huntington's Disease).
• Any cardiac dysrhythmias (i.e. atrial fibrillation)(without physicians clearance)
• Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subjects' level of consciousness.
• Known or concurrent chronic usage of psychoactive or anticonvulsive drugs. Subjects with psychiatric conditions or are on psychiatric medications (i.e. tricyclic antidepressants, MAO inhibitors, Lithium, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
• Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study, such as Reynauds Syndrome.
• Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome
• Inability to tolerate sitting still or maintain minimal movement for up to 90 minutes.

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: April 14, 2017
• First Posted: April 25, 2017
• Study Start: June 10, 2016
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: March 1, 2021
• Results First Posted: July 23, 2020

Record last verified: 2021-02

Locations

US (1)