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

NCT05657288 | Unknown

• 1 other identifier: NVT02/2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypoxia; Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hypoxia

EXPERIMENTAL

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

Interventions

Breathing mixtures of O2 and N2 and monitoring SpO2 on finger and left wrist OTHER

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.

Hypoxia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure, blood oxygen saturation and medical history

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)

Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Related 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.

  PMID: 36249475 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Simon Walzel, MSc.

  Czech Technical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional prospective study

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 20, 2022
• Study Start: December 28, 2022
• Primary Completion: May 20, 2023
• Study Completion: December 20, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

CZ (1)