Healthy
Conditions
Brief summary
Validate the performance of Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in determining functional arterial oxygen saturation (SpO2) using arterial saturation (SaO2) as a reference in the range of 70-100% in subjects of varying skin pigmentation.
Interventions
DEVICEPhilips FAST SpO2 with Masimo Pulse Oximetry Sensors
Noninvasive pulse oximeter
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
(Eligible Subjects): * Subject is 18 to 50 years of age. * Subject weighs a minimum of 110 lbs. * Baseline heart rate ≥ 45 bpm and ≤ 90 bpm. * Blood Pressure: Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 90 mmHg and ≥ 50 mmHg, and if systolic BP is lower than 100 mmHg and/or diastolic BP is lower than 60 mmHg, subject passes an orthostatic blood pressure test. * Hemoglobin value ≥ 11 g/dL. * CO value ≤ 3.0% FCOHb. * Subject can read and communicate in English and understands the study and the risks involved.
Exclusion criteria
(Ineligible Subjects) (\* = per clinician discretion): * Subject is pregnant or breastfeeding. * Subject has a BMI \> 35. * Subject has a history of fainting (vasovagal syncope), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws. * Subject has open wounds, inflamed tattoos, or piercings, and/or has any visible healing wounds that a medical professional determines may place them at an increased risk for participation. \* * Subject has finger deformities, nail deformities, nail polish, and/or gel/acrylic that can interfere with study device placement. \* * Subject has known drug or alcohol abuse. * Subject 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 (heart attack), and/or seizures. * Subject has any chronic bleeding disorder (e.g., hemophilia). * Subject has taken anticoagulant medication within the past 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDs)). * Subject has donated blood within the past 4 weeks. * Subject has any cardiac dysrhythmia (e.g., atrial fibrillation) and has not received clearance from their physician to participate. * Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. \* * Subject has taken opioid pain medication 24 hours before the study. * Subject has any infectious disease (e.g., Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles). \* * Subject is taking medications known to treat any type of infectious disease. * Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome. * Subject has had invasive surgery within the past year, including but not limited to major dental surgery, appendectomy, plastic surgery, jaw surgery, major ENT surgery, major abdominal and/or pelvic surgery, heart surgery, or thoracic surgery. \* * Subject has symptoms of congestion, head cold, or other illnesses. * Subject has been in a severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months. * Subject has any cancer or history of cancer (not including skin cancer). \* * Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease. * Subject is allergic to lidocaine, chlorhexidine, latex, adhesives, or plastic. * Subject has a heart condition, insulin-dependent diabetes, uncontrolled hypertension, or hypercholesterolemia. * Subject delivered vaginally, had a pregnancy terminated, had a miscarriage with hospitalization, or had a C-section within the past 6 months. * Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis), exercise (e.g., working out, riding a bike, riding a skateboard), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line. * Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist. * Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt) | 1 hour | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS) | 1 hour | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt CS) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI) | 1 hour | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® YI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI) | 1 hour | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DBI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx) | 1 hour | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (LNCS® Adtx) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I) | 1 hour | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® TC-I) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI) | 1 hour | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DCI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂\_i-SaO₂\_i )\^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 25 Participants |
| Race/Ethnicity, Customized Hispanic | 13 Participants |
| Race/Ethnicity, Customized Mutiracial | 2 Participants |
| Race/Ethnicity, Customized Native American | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 18 Participants |
| Region of Enrollment United States | 67 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 18 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
None listed