SpO2 Measurement Depending on Different Pulse Oximeter Averaging Time Settings

January 27, 2022 updated by: Czech Technical University in Prague
The aim of this study is to characterize the noise in the SpO2 signal depending on different pulse oximeter averaging time settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Noise in the SpO2 signal is most often caused by artifacts, such as movement artifacts, reduced perfusion, additional light and others. These artifacts can be partially removed from the SpO2 signal by different pulse oximeter settings, specifically the sensitivity mode and averaging time. It is known that when a longer averaging time is set, the measured signal contains fewer artifacts, on the other hand there is an increased risk of missing short desaturation. The aim of this work is to characterize the noise in the SpO2 signal depending on the set averaging time of the pulse oximeter based on experimental data from healthy volunteers.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Kladno, Czechia, 27201
        • Faculty of Biomedical Engineering, Czech Technical University in Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers from the Czech Technical University

Exclusion Criteria:

  • pregnancy
  • severe cardiovascular conditions
  • injury to the upper limbs or hands that could affect the peripheral perfusion
  • diabetes
  • hypotension or hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Set averaging times: 2-4 seconds and 8 seconds
SpO2 is measured by two pulse oximeters on one participant's hand (on the index finger and middle finger). One pulse oximeter is set to an averaging time of 2-4 seconds, the second pulse oximeter is set to an averaging time of 8 seconds.
Other: Movement artifact - knocking
60 seconds motion artifact simulation - knocking with sensors
Other: Movement artifact - tremor
60 seconds motion artifact simulation - tremor with sensors
Other: Artifact - ambient light
60 seconds artifact simulation - ambient light using sensor opening
Other: Artifact - low perfusion
60 seconds artifact simulation - reduced perfusion using a cuff
Other: SpO2 measurement
Two SpO2 measuring devices are active simultaneously on one hand during measurement.
Experimental: Set averaging times: 8 seconds and 16 seconds
SpO2 is measured by two pulse oximeters on one participant's hand (on the index finger and middle finger). One pulse oximeter is set to an averaging time of 8 seconds, the second pulse oximeter is set to an averaging time of 16 seconds.
Other: Movement artifact - knocking
60 seconds motion artifact simulation - knocking with sensors
Other: Movement artifact - tremor
60 seconds motion artifact simulation - tremor with sensors
Other: Artifact - ambient light
60 seconds artifact simulation - ambient light using sensor opening
Other: Artifact - low perfusion
60 seconds artifact simulation - reduced perfusion using a cuff
Other: SpO2 measurement
Two SpO2 measuring devices are active simultaneously on one hand during measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SpO2 readings with different averaging times
Time Frame: 30 minutes
Differences in the SpO2 signal during artifacts depending on the set averaging time.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech Technical University in Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2021

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

October 15, 2021

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • POAveragingTime21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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