Hypoxia
Conditions
Keywords
SpO2, Pulse oximetry, Smartwatch
Brief summary
The aim of the study is to compare the accuracy of peripheral blood oxygen saturation measurements using smartwatches from three manufacturers compared to a standard medical pulse oximeter.
Detailed description
The aim is to create a study that compares multiple smartwatch models simultaneously with a standard medical pulse oximeter using a single measurement methodology. According to the available literature, no such study exists. The methodology of the study and the subsequent statistical evaluation are based on the guidelines of the standard ČSN EN ISO 80601-2-61, which specifies requirements for the basic safety and necessary functionality of pulse oximetry devices. The comparison will be performed non-invasively in healthy volunteers during gradual desaturation in the range of 70-100 % SpO2 (normobaric hypoxia). The data obtained could help to increase the awareness of the possibilities of SpO2 monitoring using smartwatches in medical conditions that are manifested by a decrease in SpO2 level over a longer time period, where measurement with a conventional oximeter is impractical.
Interventions
OTHERHypoxia and Smartwatch model
Breathing mixtures of O2 (14 %, 12 %, 10 %) balanced with N2 and monitoring SpO2 by one of the smartwatch models on left wrist and by pulse oximeter on left index finger.
Sponsors
Czech Technical University in Prague
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
All participants go through all study arms, in random order. Two measuring devices are active simultaneously during each measurement on each participant and their functioning is compared.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Passing the initial examination, which will determine the following data: wrist circumference, heart rate, blood pressure and blood oxygen saturation
Exclusion criteria
* pregnancy * severe cardiovascular conditions * severe asthma or other severe respiratory conditions * injury to the upper limbs or hands that could affect the peripheral perfusion * diabetes * hypotension or hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Similarity of SpO2 readings | Under 1 hour | The agreement of SpO2 measurements of every model of smartwatches and reference pulse oximeter will be evaluated |
Countries
Czechia
Contacts
PRINCIPAL_INVESTIGATORJakub Rafl, PhD.
Czech Technical University in Prague
Outcome results
None listed