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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05657288
Other study ID # NVT02/2022
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 28, 2022
Est. completion date December 20, 2023

Study information

Verified date March 2023
Source Czech Technical University in Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the project is to experimentally compare SpO2 measured on a wrist by commercial Smartwach and on a finger measured by a medical-grade pulse oximeter in healthy humans during gradual desaturation in the range of 60-100% SpO2 and simultaneously during a step change from the hypoxic phase to the recovery phase (return to physiological values).


Description:

The newest models of smartwatches measure peripheral blood oxygen saturation (SpO2) and the technology is rapidly improving. The results of individual studies on the accuracy of SpO2 measurement using smartwatches from different brands are still inconclusive. The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date December 20, 2023
Est. primary completion date May 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist
Volunteers sequentially inhale three hypoxic gas mixtures each for 2.5 minute. Every measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the whole experiment, non-invasive SpO2 measurements will be performed on the middle finger and on the wrist of left hand.

Locations

Country Name City State
Czechia Czech Technical University in Prague Kladno

Sponsors (1)

Lead Sponsor Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

Rafl J, Bachman TE, Rafl-Huttova V, Walzel S, Rozanek M. Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. Digit Health. 2022 Oct 11;8:20552076221132127. doi: 10.1177/20552076221132127. eCollection 2022 Jan-Dec. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Is there any difference in measured SpO2 between finger and wrist during induced hypoxia? The agreement of SpO2 measurements of both monitoring devices will be evaluated. 1 hour
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