Oxygen Reserve Index Validation for RD Lite Sensors

February 25, 2021 updated by: Masimo Corporation
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • Masimo Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • For studies involving finger sensors: subjects with polished, gel or acrylic nails, skin abnormalities affecting the fingers or arms (such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection), distinct finger edema, substantial skin breakdown damaged and/or finger nail deformities (specific finger will not be used, unless we are specifically testing sensors in use with nail polish, gel, and /or acrylic nails).
  • Subjects who have/are currently taking anticoagulant medication.
  • Subjects who have had caffeine consumption the day of the study.
  • Subjects who have taken pain medication within 24 hours of start of study. Unless minimal preventative dose recommended for adults (discretion of physician).
  • Subjects having either signs or history of peripheral ischemia.
  • Subjects who have had invasive surgery within the past year- including but not limited to major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, Urinary tract surgery, plastic surgery, major ENT surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
  • Subjects who have had minor surgery or conditions in the past two months including but not limited to minor foot surgery (bunion), arthroscopic procedure, blood donation, plasma donation, skin biopsy/ procedures, root canal, fractures, eye surgery, and other minor procedures.
  • Subjects that have been on antibiotics had congestion, head colds, flu, ear infection, chest congestion will have a 2 week waiting period from the time of finishing medications and must have no more symptoms.
  • Subjects with claustrophobia, or anxiety.
  • Subjects who have been in severe car accidents or a similar type of accidents will have a 12 month waiting period, from the time of the accident; unless upon further medical history questions the physician determines it does not place the subject in any additional harm, increase their risk, or compromise the subjects' safety.
  • Subjects who have had a concussion will have a 12 month waiting period, from the time of the concussion.
  • Subjects with chronic unresolved asthma, lung disease or respiratory disease.
  • Subjects with allergies to lidocaine, latex, adhesives, or plastic.
  • Subjects with heart conditions, Diabetes or hypertension.
  • Subjects who have given vaginal delivery will have a 6 month waiting period. Subjects who had a pregnancy terminated, a miscarriage or had a C-section will have a 12 month waiting period.
  • Subjects who intend on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study involving an arterial blood draw and/or arterial line placement.
  • Discretion of investigator/study staff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Subject
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Specificity of ORI to Detect Drops in Oxygenation
Time Frame: 1-5 hours per subject
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
Time Frame: 1-5 hours
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
Time Frame: 1-5 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Masimo Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 29, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 29, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TP18600A-135_197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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