Hypoxia
Conditions
Keywords
Verification of SpO2 accuracy, Induced hypoxia, Owlet Smart Sock, Pulse oximeter
Brief summary
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
Interventions
DIAGNOSTIC_TESTOwlet Smart Sock Sensor 3rd Generation
Pulse Oximetry
Sponsors
Owlet Baby Care, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject is male or female, aged ≥18 and \<50. * The subject is in good general health with no evidence of any medical problems. * The subject is fluent in both written and spoken English. * The subject has provided informed consent and is willing to comply with the study procedures.
Exclusion criteria
* The subject is obese (BMI\>30). * The subject has a known history of heart disease, lung disease, kidney or liver disease. * Diagnosis of asthma, sleep apnea, or use of CPAP. * Subject has diabetes. * Subject has a clotting disorder. * The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. * The subject has any other serious systemic illness. * The subject is a current smoker. * Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. * The subject has a history of fainting or vasovagal response. * The subject has a history of sensitivity to local anesthesia. * The subject has a diagnosis of Raynaud's disease. * The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). * The subject is pregnant, lactating or trying to get pregnant. * The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. * The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SpO2 Accuracy (Arms) of ≤3 Between 70 and 100% | 1 hour | Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ARMS SpO2 70-100% Comparison to Reference CO-Oximetry Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less. | 14 |
| ARMS SpO2 70-100% Comparison to Reference CO-Oximetry Accuracy of the Owlet Smart Sock Sensor 3rd Generation: The purpose of this study was to validate the SpO2 accuracy of the Owlet Smart Sock Sensor 3rd Generation during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less. | 351 |
| Total | 365 |
Baseline characteristics
| Characteristic | ARMS SpO2 70-100% |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 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 | 5 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
| Skin Tone Dark | 1 Participants |
| Skin Tone Dark-Medium | 4 Participants |
| Skin Tone Light | 1 Participants |
| Skin Tone Light- Medium | 4 Participants |
| Skin Tone Medium | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
SpO2 Accuracy (Arms) of ≤3 Between 70 and 100%
Determination of Average Root Mean Square SpO2 Accuracy of the Owlet Smart Sock 3rd Generation
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ARMS SpO2 70-100%, Oximeter #1 (Left) | SpO2 Accuracy (Arms) of ≤3 Between 70 and 100% | 2.10 Percentage |
| ARMS SpO2 70-100%, Oximeter #2 (Right) | SpO2 Accuracy (Arms) of ≤3 Between 70 and 100% | 2.19 Percentage |