Peripheral Oxygen Saturation Measurement, SpO2
Conditions
Brief summary
The purpose of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data on human participants.
Detailed description
The primary objective of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data (simulating blood sample Spo2) on adult human subjects. Transfer standard is a validated pulse oximetry equipment with a calibration directly traceable to CO-oximetry. Test method and protocol is developed according to ISO 80601-2-61:2017 annex EE.3 (PROCEDURE for non-invasive laboratory testing on healthy adult volunteers) The safety objective is to collect safety information, including type and number of AEs, SAEs, and device issues. This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.
Interventions
DEVICESpO2 Sensor Testing
Participants participating in this study will be connected sensors.The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participant is adult 18-50 years of age. 2. Biological Male or female of any race 3. Participant is a non-smoker or who has not smoked within 2 days prior. 4. Participant must have the ability to understand and provide written informed consent. 5. Participant is adult must be willing and able to comply with study procedures and duration.
Exclusion criteria
1. Participant is considered as being morbidly obese (defined as BMI greater than 39.5) 2. Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular sites utilized). 3. Tattoo in the optical path which would limit the ability to test sites needed for the study. 4. Females who are pregnant - confirmed by self-performed and self-reported positive urine pregnancy test performed on the day of the study unless the participant is known to be not of child-bearing potential 5. Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels greater than 3% as assessed per site standard operation procedure. 6. Participants with self-reported respiratory conditions such as: uncontrolled/severe asthma, flu, pneumonia/bronchitis, shortness of breath/respiratory distress, unresolved respiratory or lung surgery, emphysema, COPD, lung disease, and/or recent COVID (last 2 months). 7. Participants with self-reported heart or cardiovascular conditions such as: cardiovascular surgery - except successful minor surgery without clinical symptoms (i.e., PFO, PDA), chest pain (angina), previous heart attack, blocked artery, unexplained shortness of breath, congestive heart failure (CHF), history of stroke, transient ischemic attack, carotid artery disease, myocardial ischemia, myocardial infarction, cardiomyopathy, Cardiovascular implantable active medical device (such as pacemaker or automatic defibrillator), Heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia, and/or High blood pressure: systolic greater than140 mmHg or diastolic greater than 90 mmHg on 3 consecutive readings 8. Participants with self-reported health conditions such as: diabetes, uncontrolled thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures), epilepsy, history of unexplained syncope, recent history of frequent migraine headaches, recent symptomatic head injury (within the last 2 months), Cancer requiring chemotherapy, radiation, or currently on treatment, Participants with self-reported known clotting disorders, history of bleeding disorders or personal history of prolonged bleeding from injury, history of blood clots, hemophilia, current use of blood thinner: prescription or daily use of aspirin, and/or Sickle Cell Trait or Disease. 10\. Participants with severe contact allergies to standard adhesives, latex, silicone, or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported) 11. Unwillingness or inability to remove colored nail polish or non-clear artificial nails from test digits 12. Surgical hardware in pathway which would limit the ability to test sites needed for the study 13. Other known health condition, should be considered upon disclosure in health assessment form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of Subject SpO2 Percentage Sensor Data With Transfer Standard Measurements for Validation | 2 Weeks | The collection of SpO2 percentage sensor data with simultaneous transfer standard SpO2 percentage measurements (simulating blood sample SpO2) from each subject enrolled in the study. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Safety Events | 2 Weeks | The collection of the number of adverse events, serious adverse events, and/or device deficiencies reported on all enrolled subjects in the study. |
Countries
United States
Participant flow
Recruitment details
A total of 32 participants were enrolled; 31 subjects completed all study procedures.
Participants by arm
| Arm | Count |
|---|---|
| SpO2 Measurements - All Subjects Participants participating in this study will be connected to sensors. The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | SpO2 Measurements - All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 28.42 years STANDARD_DEVIATION 8.83 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 16 Participants |
| Skin Pigment Monk 01 (Lightest Skin Tone) | 4 Participants |
| Skin Pigment Monk 02 | 4 Participants |
| Skin Pigment Monk 03 | 1 Participants |
| Skin Pigment Monk 04 | 2 Participants |
| Skin Pigment Monk 05 | 5 Participants |
| Skin Pigment Monk 06 | 2 Participants |
| Skin Pigment Monk 07 | 2 Participants |
| Skin Pigment Monk 08 | 7 Participants |
| Skin Pigment Monk 09 | 2 Participants |
| Skin Pigment Monk 10 (Darkest Skin Tone) | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 1 / 32 |
| serious Total, serious adverse events | 1 / 32 |
Outcome results
Primary
Collection of Subject SpO2 Percentage Sensor Data With Transfer Standard Measurements for Validation
The collection of SpO2 percentage sensor data with simultaneous transfer standard SpO2 percentage measurements (simulating blood sample SpO2) from each subject enrolled in the study.
Time frame: 2 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SpO2 Measurements - All Subjects | Collection of Subject SpO2 Percentage Sensor Data With Transfer Standard Measurements for Validation | 31 data sets |
Other Pre-specified
Number of Safety Events
The collection of the number of adverse events, serious adverse events, and/or device deficiencies reported on all enrolled subjects in the study.
Time frame: 2 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SpO2 Measurements - All Subjects | Number of Safety Events | Adverse Event | 1 safety events |
| SpO2 Measurements - All Subjects | Number of Safety Events | Serious Adverse Event | 1 safety events |