Healthy
Conditions
Brief summary
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Subgroups will be analyzed by skin pigmentation and self-identified race/ethnicity information. Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.
Interventions
DEVICEINVSENSOR00050
Noninvasive pulse oximeter sensor
DEVICERD SET SpO2
Noninvasive pulse oximeter sensor
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
* Subject is 18 to 50 years of age. * Subject weighs a minimum of 110 lbs. * Subject has a hemoglobin value ≥ 11 g/dL. * Subject's baseline heart rate is ≥ 45 bpm and ≤ 85 bpm. * Subject's CO value is ≤ 2.0% FCOHb. * Subject's 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. * Subject is able to read and communicate in English and understands the study and the risks involved.
Exclusion criteria
* Subject is pregnant. * 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 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 Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome. * Subject has any symptomatic 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 active signs and/or symptoms of infectious disease (e.g. hepatitis, HIV, tuberculosis, flu, malaria, measles, etc.).\* * 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, or uncontrolled hypertension. * Subject has delivered vaginally, has had a pregnancy terminated, 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 (working out, riding a bike, riding a skateboard, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line. * Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of the investigator/study staff).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation (SpO2) Accuracy of INVSENSOR00050 | 1-5 hours | Performance of the INVSENSOR00050 sensor will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the accuracy root mean square (ARMS) value. The ARMS value will be reported as % of oxygen saturated hemoglobin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the Median Bias Between Subgroups for the INVSENSOR00050 Sensor | 1-5 hours | The secondary outcome is to perform equivalence tests between identified subgroups based on skin pigmentation and/or self-identified race/ethnicity. Since the pulse oximeter displays saturation in integer values, equivalence limits will be set to ± 1% SpO2. A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the INVSENSOR00050 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1% SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05. |
| Comparison of the Median Bias Between Subgroups for the RD SET SpO2 Sensors | 1-5 hours | The secondary outcome is to perform equivalence tests between identified subgroups based on skin pigmentation and/or self-identified race/ethnicity. Since the pulse oximeter displays saturation in integer values, equivalence limits will be set to ± 1% SpO2. A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the RD SET SpO2 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulse Oximeters All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors.
INVSENSOR00050: Noninvasive pulse oximeter sensor
RD SET SpO2: Noninvasive pulse oximeter sensor | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet eligibility criteria | 8 |
| Overall Study | Did not proceed due to time constraints | 5 |
| Overall Study | Failure to place intravenous or arterial line | 3 |
Baseline characteristics
| Characteristic | Pulse Oximeters |
|---|---|
| Age, Customized 18 to 50 years of age | 38 Participants |
| Age, Customized < 18 years of age | 0 Participants |
| Age, Customized > 50 years of age | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 18 Participants |
| Race/Ethnicity, Customized Caucasian | 17 Participants |
| Race/Ethnicity, Customized Caucasian/Black or African American | 1 Participants |
| Race/Ethnicity, Customized Hispanic/Black or African American | 1 Participants |
| Race/Ethnicity, Customized Native American/Black or African American | 1 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 1 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Oxygen Saturation (SpO2) Accuracy of INVSENSOR00050
Performance of the INVSENSOR00050 sensor will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the accuracy root mean square (ARMS) value. The ARMS value will be reported as % of oxygen saturated hemoglobin.
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pulse Oximeters | Oxygen Saturation (SpO2) Accuracy of INVSENSOR00050 | 1.5 % of oxygen saturated hemoglobin |
Secondary
Comparison of the Median Bias Between Subgroups for the INVSENSOR00050 Sensor
The secondary outcome is to perform equivalence tests between identified subgroups based on skin pigmentation and/or self-identified race/ethnicity. Since the pulse oximeter displays saturation in integer values, equivalence limits will be set to ± 1% SpO2. A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the INVSENSOR00050 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1% SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.
Time frame: 1-5 hours
Population: Due to early termination of the study, the subgroups were not well balanced for secondary outcomes analysis due to lack for female subjects, especially dark skin pigmented females. Hence the analysis is not fully representative. However, the equivalence analysis was conducted for the two pigment subgroups with available data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pulse Oximeters | Comparison of the Median Bias Between Subgroups for the INVSENSOR00050 Sensor | Dark pigmented subgroup | -0.1 percentage of SpO2 |
| Pulse Oximeters | Comparison of the Median Bias Between Subgroups for the INVSENSOR00050 Sensor | Light pigmented subgroup | -1.0 percentage of SpO2 |
p-value: 0.00097Two One Sided Tests (TOST)
Secondary
Comparison of the Median Bias Between Subgroups for the RD SET SpO2 Sensors
The secondary outcome is to perform equivalence tests between identified subgroups based on skin pigmentation and/or self-identified race/ethnicity. Since the pulse oximeter displays saturation in integer values, equivalence limits will be set to ± 1% SpO2. A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the RD SET SpO2 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.
Time frame: 1-5 hours
Population: Due to early termination of the study, the subgroups were not well balanced for secondary outcomes analysis due to lack for female subjects, especially dark skin pigmented females. Hence the analysis is not fully representative. However, the equivalence analysis was conducted for the two pigment subgroups with available data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pulse Oximeters | Comparison of the Median Bias Between Subgroups for the RD SET SpO2 Sensors | Dark pigmented subgroup | -0.3 percentage of SpO2 |
| Pulse Oximeters | Comparison of the Median Bias Between Subgroups for the RD SET SpO2 Sensors | Light pigmented subgroup | -0.9 percentage of SpO2 |
p-value: 0Two One-Sided Tests (TOST)