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Evaluation of SpO2 Measurement Using a Smartwatch (ESMUS)

Primary Purpose

Hypoxia, Hypercapnia

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Hypoxic gas mixture
Hypercapnic and hypoxic gas mixture
SpO2 measurement
Sponsored by
Czech Technical University in Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxia focused on measuring SpO2, pulse oximetry, smartwatch

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy volunteers from the Czech Technical University

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

Sites / Locations

  • Faculty of Biomedical Engineering, Czech Technical University in Prague

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hypoxic

Hypercapnic

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 1, 2021
Last Updated
January 27, 2022
Sponsor
Czech Technical University in Prague
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1. Study Identification

Unique Protocol Identification Number
NCT04780724
Brief Title
Evaluation of SpO2 Measurement Using a Smartwatch
Acronym
ESMUS
Official Title
Evaluation of SpO2 Measurement Using a Smartwatch
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Recently, wearables, like smartwatches, have been gaining new possibilities in monitoring biological signals and they are used for home monitoring of health conditions. The newest models of smartwatches even measure peripheral blood oxygen saturation (SpO2). 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. Healthy participants will breathe oxygen-reduced mixtures (the hypoxic gas mixture of 12% O2 and 88% N2 and the hypercapnic and hypoxic gas mixture of 12% O2, 5% CO2, and 83% N2), which will temporarily reduce their blood oxygen saturation. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypercapnia
Keywords
SpO2, pulse oximetry, smartwatch

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypoxic
Arm Type
Experimental
Arm Description
Participants inhale ambient air, the hypoxic gas mixture, and ambient air.
Arm Title
Hypercapnic
Arm Type
Experimental
Arm Description
Participants inhale ambient air, the hypercapnic and hypoxic gas mixture, and the ambient air.
Intervention Type
Other
Intervention Name(s)
Hypoxic gas mixture
Intervention Description
Gas mixture of 12% O2 and 88% N2 for five minutes.
Intervention Type
Other
Intervention Name(s)
Hypercapnic and hypoxic gas mixture
Intervention Description
Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes.
Intervention Type
Other
Intervention Name(s)
SpO2 measurement
Intervention Description
Two SpO2 measuring devices are active simultaneously during measurement.
Primary Outcome Measure Information:
Title
Similarity of SpO2 readings
Description
The agreement of SpO2 measurements of both monitoring devices will be evaluated.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy volunteers from the Czech Technical University 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronika Rafl Huttova
Organizational Affiliation
Czech Technical University in Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Biomedical Engineering, Czech Technical University in Prague
City
Kladno
ZIP/Postal Code
27201
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28802098
Citation
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.
Results Reference
background
PubMed Identifier
32633688
Citation
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.
Results Reference
background
PubMed Identifier
36249475
Citation
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.
Results Reference
derived

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Evaluation of SpO2 Measurement Using a Smartwatch

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