Healthy
Conditions
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.
Interventions
DEVICEOxygen Reserve Index - RD Lite Sensors
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of ORI to Detect Drops in Oxygenation | 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). |
| Sensitivity of ORI to Detect Drops in Oxygenation | 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). |
| Concordance of ORI to Detect Drops in Oxygenation | 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%). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxygen Reserve Index (ORi) - RD Lite Sensors All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Oxygen Reserve Index - RD Lite Sensors. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Oxygen Reserve Index (ORi) - RD Lite Sensors |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Race/Ethnicity, Customized African American | 12 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 5 Participants |
| Race/Ethnicity, Customized Hispanic | 13 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 1 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
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%).
Time frame: 1-5 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Concordance of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 110 mmHg | 88.83 percentage of accuracy |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Concordance of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 120 mmHg | 92.46 percentage of accuracy |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Concordance of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 130 mmHg | 91.47 percentage of accuracy |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Concordance of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 140 mmHg | 93.33 percentage of accuracy |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Concordance of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 150 mmHg | 93.00 percentage of accuracy |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Concordance of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 170 mmHg | 90.80 percentage of accuracy |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Concordance of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 180 mmHg | 93.78 percentage of accuracy |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Concordance of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 190 mmHg | 94.39 percentage of accuracy |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Concordance of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 160 mmHg | 92.16 percentage of accuracy |
Primary
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).
Time frame: 1-5 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Sensitivity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 180 mmHg | 85.40 percentage of true positives |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Sensitivity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 190 mmHg | 88.27 percentage of true positives |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Sensitivity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 110 mmHg | 84.96 percentage of true positives |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Sensitivity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 120 mmHg | 89.85 percentage of true positives |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Sensitivity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 130 mmHg | 85.51 percentage of true positives |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Sensitivity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 140 mmHg | 89.47 percentage of true positives |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Sensitivity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 150 mmHg | 86.17 percentage of true positives |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Sensitivity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 160 mmHg | 87.13 percentage of true positives |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Sensitivity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 170 mmHg | 83.96 percentage of true positives |
Primary
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).
Time frame: 1-5 hours per subject
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Specificity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 110 mmHg | 98.50 percentage of true negative |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Specificity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 120 mmHg | 96.68 percentage of true negative |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Specificity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 130 mmHg | 98.89 percentage of true negative |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Specificity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 140 mmHg | 96.95 percentage of true negative |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Specificity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 150 mmHg | 97.67 percentage of true negative |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Specificity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 160 mmHg | 94.75 percentage of true negative |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Specificity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 170 mmHg | 93.60 percentage of true negative |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Specificity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 180 mmHg | 96.23 percentage of true negative |
| Oxygen Reserve Index (ORi) - RD Lite Sensors | Specificity of ORI to Detect Drops in Oxygenation | PaO2 Threshold: 190 mmHg | 95.82 percentage of true negative |