Oximetry
Conditions
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_TESThypoxia
Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.
Sponsors
Withings
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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 has both wrist circumferences between 14 and 22cm. * 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. * The subject has piercings that may cause air leaks during the test * The subject has 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 a resting heartrate over 120, Systolic BP is over 150, diastolic BP is over 90 or room air SpO2 is less than 94%. * The subject has carboxyhemoglobin over 3% as measured by Lab blood gas analysis. * The subject has any other condition, which in the opinion of the investigators' would make them unsuitable to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RMSE Compared to CO-oximetry | 1 hour | Root Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter. |
Countries
United States
Participant flow
Recruitment details
First enrolment: 2020/03/11 Last subject completed: 2020/03/12 The study included eligible volunteers at UCSF. The investigators selected subjects, balanced in terms of gender, age, and skin pigmentation. Participation to the study was offered to the subjects until the target headcounts was reached.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 27.1 year STANDARD_DEVIATION 3.9 |
| BMI (kg/m²) | 23.4 kg.m-² STANDARD_DEVIATION 2.1 |
| Height | 168.7 cm STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
| Skin tone Dark skin tone | 3 Participants |
| Skin tone Fair skin tone | 4 Participants |
| Skin tone Medium skin tone | 7 Participants |
| Weight | 66.6 kg STANDARD_DEVIATION 8.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
None listed