Evaluation of SpO2 Measurement Using a Smartwatch

NCT04780724 | Completed

• 1 other identifier: smartwatch21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the measurement of peripheral blood oxygen saturation using a smartwatch with a medical-grade pulse oximeter.

Conditions

Hypoxia; Hypercapnia

Keywords

SpO2; pulse oximetry; smartwatch

Outcome Measures

Primary Outcomes (1)

• Similarity of SpO2 readings

  The agreement of SpO2 measurements of both monitoring devices will be evaluated.

  2 hours

Study Arms (2)

Hypoxic

EXPERIMENTAL

Participants inhale ambient air, the hypoxic gas mixture, and ambient air.

Other: Hypoxic gas mixture; Other: SpO2 measurement

Hypercapnic

EXPERIMENTAL

Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air.

Other: Hypercapnic and hypoxic gas mixture; Other: SpO2 measurement

Interventions

Hypoxic gas mixture OTHER

Gas mixture of 12% O2 and 88% N2 for five minutes.

Hypoxic

Hypercapnic and hypoxic gas mixture OTHER

Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes.

Hypercapnic

SpO2 measurement OTHER

Two SpO2 measuring devices are active simultaneously during measurement.

Hypercapnic; Hypoxic

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers from the Czech Technical University

You may not qualify if:

• 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

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (1)

Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Related Publications (3)

• Rafl J, Kulhanek F, Kudrna P, Ort V, Roubik K. Response time of indirectly accessed gas exchange depends on measurement method. Biomed Tech (Berl). 2018 Nov 27;63(6):647-655. doi: 10.1515/bmt-2017-0070.

  PMID: 28802098 BACKGROUND

• Lauterbach CJ, Romano PA, Greisler LA, Brindle RA, Ford KR, Kuennen MR. Accuracy and Reliability of Commercial Wrist-Worn Pulse Oximeter During Normobaric Hypoxia Exposure Under Resting Conditions. Res Q Exerc Sport. 2021 Sep;92(3):549-558. doi: 10.1080/02701367.2020.1759768. Epub 2020 Jul 7.

  PMID: 32633688 BACKGROUND

• 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.

  PMID: 36249475 DERIVED

MeSH Terms

Conditions

Hypoxia; Hypercapnia

Interventions

nitrox

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Veronika Rafl Huttova

  Czech Technical University in Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants go through all study arms, in random order. Two measuring devices are active simultaneously during measurement on each participant and their functioning is compared.

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: February 15, 2021
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)