HYPOWATCH: SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter During Hypoxia

Sponsor
Czech Technical University in Prague (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05657288
Collaborator
(none)
40
1
1
11.7
3.4

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Interventional prospective studyInterventional prospective study
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
SpO2 Comparison Between Commercial Smartwatch and Medical-grade Pulse Oximeter
Anticipated Study Start Date :
Dec 28, 2022
Anticipated Primary Completion Date :
May 20, 2023
Anticipated Study Completion Date :
Dec 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hypoxia

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Is there any difference in measured SpO2 between finger and wrist during induced hypoxia? [1 hour]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Czech Technical University in Prague Kladno Czechia 27201

Sponsors and Collaborators

  • Czech Technical University in Prague

Investigators

  • Principal Investigator: Simon Walzel, MSc., Czech Technical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Czech Technical University in Prague
ClinicalTrials.gov Identifier:
NCT05657288
Other Study ID Numbers:
  • NVT02/2022
First Posted:
Dec 20, 2022
Last Update Posted:
Dec 28, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2022