SpO2 Measurement Depending on Different Pulse Oximeter Averaging Time Settings

NCT04933773 | Completed

• 1 other identifier: POAveragingTime21
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Movement Artifacts During SpO2 Measurements; Reduced Perfusion During SpO2 Measurements

Keywords

pulse oximetry; SpO2; averaging time; motion artifacts

Outcome Measures

Primary Outcomes (1)

• SpO2 readings with different averaging times

  Differences in the SpO2 signal during artifacts depending on the set averaging time.

  30 minutes

Study Arms (2)

Set averaging times: 2-4 seconds and 8 seconds

EXPERIMENTAL

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; Other: Movement artifact - tremor; Other: Artifact - ambient light; Other: Artifact - low perfusion; Other: SpO2 measurement

Set averaging times: 8 seconds and 16 seconds

EXPERIMENTAL

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; Other: Movement artifact - tremor; Other: Artifact - ambient light; Other: Artifact - low perfusion; Other: SpO2 measurement

Interventions

Movement artifact - knocking OTHER

60 seconds motion artifact simulation - knocking with sensors

Set averaging times: 2-4 seconds and 8 seconds; Set averaging times: 8 seconds and 16 seconds

Movement artifact - tremor OTHER

60 seconds motion artifact simulation - tremor with sensors

Set averaging times: 2-4 seconds and 8 seconds; Set averaging times: 8 seconds and 16 seconds

Artifact - ambient light OTHER

60 seconds artifact simulation - ambient light using sensor opening

Set averaging times: 2-4 seconds and 8 seconds; Set averaging times: 8 seconds and 16 seconds

Artifact - low perfusion OTHER

60 seconds artifact simulation - reduced perfusion using a cuff

Set averaging times: 2-4 seconds and 8 seconds; Set averaging times: 8 seconds and 16 seconds

SpO2 measurement OTHER

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

Set averaging times: 2-4 seconds and 8 seconds; Set averaging times: 8 seconds and 16 seconds

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers from the Czech Technical University

You may not qualify if:

• pregnancy
• severe cardiovascular 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)

Faculty of Biomedical Engineering, Czech Technical University in Prague

Kladno, 27201, Czechia

Location

Study Officials

• Veronika Rafl Huttova

  Czech Technical University in Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: May 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)