SpO2 Measurement Depending on Different Pulse Oximeter Averaging Time Settings

NCT ID: NCT04933773

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2021-10-15

Brief Summary

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The aim of this study is to characterize the noise in the SpO2 signal depending on different pulse oximeter averaging time settings.

Detailed Description

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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.

Conditions

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Movement Artifacts During SpO2 Measurements Reduced Perfusion During SpO2 Measurements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants go through all study arms, in random order. Two pulse oximeters with different averaging time settings are active simultaneously during measurement on each participant and the measured signal is compared.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Movement artifact - knocking

Intervention Type OTHER

60 seconds motion artifact simulation - knocking with sensors

Movement artifact - tremor

Intervention Type OTHER

60 seconds motion artifact simulation - tremor with sensors

Artifact - ambient light

Intervention Type OTHER

60 seconds artifact simulation - ambient light using sensor opening

Artifact - low perfusion

Intervention Type OTHER

60 seconds artifact simulation - reduced perfusion using a cuff

SpO2 measurement

Intervention Type OTHER

Two SpO2 measuring devices are active simultaneously on one hand during measurement.

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.

Group Type EXPERIMENTAL

Movement artifact - knocking

Intervention Type OTHER

60 seconds motion artifact simulation - knocking with sensors

Movement artifact - tremor

Intervention Type OTHER

60 seconds motion artifact simulation - tremor with sensors

Artifact - ambient light

Intervention Type OTHER

60 seconds artifact simulation - ambient light using sensor opening

Artifact - low perfusion

Intervention Type OTHER

60 seconds artifact simulation - reduced perfusion using a cuff

SpO2 measurement

Intervention Type OTHER

Two SpO2 measuring devices are active simultaneously on one hand during measurement.

Interventions

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Movement artifact - knocking

60 seconds motion artifact simulation - knocking with sensors

Intervention Type OTHER

Movement artifact - tremor

60 seconds motion artifact simulation - tremor with sensors

Intervention Type OTHER

Artifact - ambient light

60 seconds artifact simulation - ambient light using sensor opening

Intervention Type OTHER

Artifact - low perfusion

60 seconds artifact simulation - reduced perfusion using a cuff

Intervention Type OTHER

SpO2 measurement

Two SpO2 measuring devices are active simultaneously on one hand during measurement.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Czech Technical University in Prague

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronika Rafl Huttova

Role: PRINCIPAL_INVESTIGATOR

Czech Technical University in Prague

Locations

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Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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POAveragingTime21

Identifier Type: -

Identifier Source: org_study_id

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