Movement Artifacts During SpO2 MeasurementsNCT04933773
SpO2 Measurement Depending on Different Pulse Oximeter Averaging Time Settings
A study testing Movement artifact - knocking, Movement artifact - tremor and Artifact - ambient light in people with Movement Artifacts During SpO2 Measurements and Reduced Perfusion During SpO2 Measurements, run by Czech Technical University in Prague at 1 site in Czechia.
Trial summary
The aim of this study is to characterize the noise in the SpO2 signal depending on different pulse oximeter averaging time settings. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Artifacts During SpO2 Measurements, Reduced Perfusion During SpO2 Measurements
- What is being tested?
- Movement artifact - knocking, Movement artifact - tremor and Artifact - ambient light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCzechia
- Study dates
- 15 May 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers from the Czech Technical University
Who cannot join
- pregnancy
- severe cardiovascular conditions
- injury to the upper limbs or hands that could affect the peripheral perfusion
- diabetes
- hypotension or hypertension
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Faculty of Biomedical Engineering, Czech Technical University in Prague
Kladno, 27201
About this study
The aim of this study is to characterize the noise in the SpO2 signal depending on different pulse oximeter averaging time settings.
Read the 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.
- Being tested
- Movement artifact - knocking, Movement artifact - tremor, Artifact - ambient light, Artifact - low perfusion, SpO2 measurement
- Keywords
- pulse oximetry, SpO2, averaging time, motion artifacts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement artifact - knockingOther
60 seconds motion artifact simulation - knocking with sensors
Movement artifact - tremorOther
60 seconds motion artifact simulation - tremor with sensors
Artifact - ambient lightOther
60 seconds artifact simulation - ambient light using sensor opening
Artifact - low perfusionOther
60 seconds artifact simulation - reduced perfusion using a cuff
SpO2 measurementOther
Two SpO2 measuring devices are active simultaneously on one hand during measurement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Movement artifact - knocking; Other: Movement artifact - tremor; Other: Artifact - ambient light; Other: Artifact - low perfusion; Other: SpO2 measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 readings with different averaging times
Differences in the SpO2 signal during artifacts depending on the set averaging time.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start15 May 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement Artifacts During SpO2 MeasurementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronika Rafl Huttova, Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933773
- Sponsor's protocol ID
- POAveragingTime21
- Status last verified
- Jan 2022
- First submitted
- 14 Jun 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Measurement Depending on Different Pulse Oximeter Averaging Time Settings
- ClinicalTrials.gov ID
- NCT04933773
- Acronym / sponsor ID
- POAveragingTime21
- Keywords
- pulse oximetry, SpO2, averaging time, motion artifacts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to characterize the noise in the SpO2 signal depending on different pulse oximeter averaging time settings.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Set averaging times: 2-4 seconds and 8 seconds | Experimental | Other: Movement artifact - knocking, Other: Movement artifact - tremor, Other: Artifact - ambient light, Other: Artifact - low perfusion, Other: SpO2 measurementSpO2 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. |
| Set averaging times: 8 seconds and 16 seconds | Experimental | Other: Movement artifact - knocking, Other: Movement artifact - tremor, Other: Artifact - ambient light, Other: Artifact - low perfusion, Other: SpO2 measurementSpO2 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy volunteers from the Czech Technical University
Key exclusion criteria (5 listed)
- pregnancy
- severe cardiovascular conditions
- injury to the upper limbs or hands that could affect the peripheral perfusion
- diabetes
- hypotension or hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Movement artifact - knocking60 seconds motion artifact simulation - knocking with sensors | Other | Set averaging times: 2-4 seconds and 8 seconds, Set averaging times: 8 seconds and 16 seconds |
| Movement artifact - tremor60 seconds motion artifact simulation - tremor with sensors | Other | Set averaging times: 2-4 seconds and 8 seconds, Set averaging times: 8 seconds and 16 seconds |
| Artifact - ambient light60 seconds artifact simulation - ambient light using sensor opening | Other | Set averaging times: 2-4 seconds and 8 seconds, Set averaging times: 8 seconds and 16 seconds |
| Artifact - low perfusion60 seconds artifact simulation - reduced perfusion using a cuff | Other | Set averaging times: 2-4 seconds and 8 seconds, Set averaging times: 8 seconds and 16 seconds |
| SpO2 measurementTwo SpO2 measuring devices are active simultaneously on one hand during measurement. | Other | Set averaging times: 2-4 seconds and 8 seconds, Set averaging times: 8 seconds and 16 seconds |
Primary outcome
SpO2 readings with different averaging times
Time frame: 30 minutes
Differences in the SpO2 signal during artifacts depending on the set averaging time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronika Rafl Huttova principal investigator
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement artifact - knocking, Movement artifact - tremor and Artifact - ambient light in people with Movement Artifacts During SpO2 Measurements and Reduced Perfusion During SpO2 Measurements, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 readings with different averaging times (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.