Perfusion IndexPICOMPNCT06635018
Effect of Pulse Oximeter Device on Measured Perfusion Index Values
A study testing Resting conditions, Movement artifacts and Circulation constriction in people with Perfusion Index, run by Czech Technical University in Prague at 1 site in Czechia.
Trial summary
The aim of this study is to experimentally determine the effect of pulse oximeters from different manufacturers on measured perfusion index values in healthy subjects at rest and with and without motion artifacts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perfusion Index
- What is being tested?
- Resting conditions, Movement artifacts and Circulation constriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2024to 30 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy Adult Volunteer
Who cannot join
- Post-traumatic upper limb conditions affecting finger perfusion
- Injuries or diseases of the skin of the fingers
- Any acute phase of any disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to experimentally determine the effect of pulse oximeters from different manufacturers on measured perfusion index values in healthy subjects at rest and with and without motion artifacts.
Read the detailed description
Perfusion index (PI) is one of the many vital signs monitored to assess the clinical status of a patient. PI is determined from the pulsatile part of the plethysmographic curve, with typical values measured on the fingers ranging from 0.02% to 20%. Although PI is a relatively newly measured parameter, it has already found application in many areas of clinical medicine. It can be used as an indicator of the severity of health status in different groups of critically ill patients, e.g. in patients with sepsis, in patients after cardiac arrest, for early detection of critical heart defects, for indirect assessment of patient pain, as an indicator of fluid therapy and reactivity, or for assessment and evaluation of anaesthesia in the operating room. However, there is currently no standardised calculation of PI and different manufacturers use different algorithms for the calculation. The consequence is that absolute measured values cannot be compared between devices.
- Conditions
- Perfusion Index
- Being tested
- Resting conditions, Movement artifacts, Circulation constriction
- Keywords
- Perfusion index, Pulse oximetry, Nociception during Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting conditionsOther
The volunteer's hands are at rest and PI readings are taken for six minutes. After two minutes, there is always a randomized rotation of the sensors between the fingers.
Movement artifactsOther
The volunteer periodically spreads his/her fingers and clenches them into a fist, and PI readings are taken for six minutes. After two minutes there is always a randomized rotation of sensors between the fingers.
Circulation constrictionOther
The volunteer's arm is constricted using a cuff to measure non-invasive blood pressure. The perfusion index value is monitored during the time of cuff pressure and cuff release. The measurement is followed by a 4-minute pause to allow the vascular supply to stabilize, the sensors are randomly rotated, and the measurement is repeated.
| Study group | Role | What they receive |
|---|---|---|
| Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index | Experimental | Three finger pulse oximeter sensors from different manufacturers are placed on the middle fingers of one hand. Three interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction). Receives: Other: Resting conditions; Other: Movement artifacts; Other: Circulation constriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction
Perfusion index values will be measured and compared using pulse oximeters from different manufacturers under various conditions, including resting state, movement artifacts, and circulatory restriction. This evaluation will provide a direct comparison of the variability in perfusion index measurements across devices under each condition.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Feb 2024
- Primary completion30 Oct 2024
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion IndexStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional prospective single-arm study
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, Prof., Study chair, Czech Technical University, Fac. of Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635018
- Sponsor's protocol ID
- NVT_01_2024
- Acronym
- PICOMP
- Status last verified
- Mar 2026
- First submitted
- 1 Oct 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulse Oximeter Device on Measured Perfusion Index Values
- ClinicalTrials.gov ID
- NCT06635018
- Acronym / sponsor ID
- PICOMP / NVT_01_2024
- Conditions
- Perfusion Index
- Keywords
- Perfusion index, Pulse oximetry, Nociception during Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 10 Oct 2024 (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 experimentally determine the effect of pulse oximeters from different manufacturers on measured perfusion index values in healthy subjects at rest and with and without motion artifacts.
Detailed description
Perfusion index (PI) is one of the many vital signs monitored to assess the clinical status of a patient. PI is determined from the pulsatile part of the plethysmographic curve, with typical values measured on the fingers ranging from 0.02% to 20%. Although PI is a relatively newly measured parameter, it has already found application in many areas of clinical medicine. It can be used as an indicator of the severity of health status in different groups of critically ill patients, e.g. in patients with sepsis, in patients after cardiac arrest, for early detection of critical heart defects, for indirect assessment of patient pain, as an indicator of fluid therapy and reactivity, or for assessment and evaluation of anaesthesia in the operating room. However, there is currently no standardised calculation of PI and different manufacturers use different algorithms for the calculation. The consequence is that absolute measured values cannot be compared between devices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional prospective single-arm study
| Arm | Type | Receives |
|---|---|---|
| Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index | Experimental | Other: Resting conditions, Other: Movement artifacts, Other: Circulation constrictionThree finger pulse oximeter sensors from different manufacturers are placed on the middle fingers of one hand. Three interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Adult Volunteer
Key exclusion criteria (3 listed)
- Post-traumatic upper limb conditions affecting finger perfusion
- Injuries or diseases of the skin of the fingers
- Any acute phase of any disease
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 |
|---|---|---|
| Resting conditionsThe volunteer's hands are at rest and PI readings are taken for six minutes. After two minutes, there is always a randomized rotation of the sensors between the fingers. | Other | Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index |
| Movement artifactsThe volunteer periodically spreads his/her fingers and clenches them into a fist, and PI readings are taken for six minutes. After two minutes there is always a randomized rotation of sensors between the fingers. | Other | Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index |
| Circulation constrictionThe volunteer's arm is constricted using a cuff to measure non-invasive blood pressure. The perfusion index value is monitored during the time of cuff pressure and cuff release. The measurement is followed by a 4-minute pause to allow the vascular supply to stabilize, the sensors are randomly rotated, and the measurement is repeated. | Other | Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index |
Primary outcome
Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction
Time frame: 1 hour
Perfusion index values will be measured and compared using pulse oximeters from different manufacturers under various conditions, including resting state, movement artifacts, and circulatory restriction. This evaluation will provide a direct comparison of the variability in perfusion index measurements across devices under each condition.
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 11 Mar 2026.
- Individual participant dataSharing planned: Yes. The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
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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.
Karel Roubik, Prof. study chair
Czech Technical University, Fac. of Biomedical Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resting conditions, Movement artifacts and Circulation constriction in people with Perfusion Index, 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 3 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 11 Mar 2026. 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?
Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction (time frame: 1 hour). 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 11 Mar 2026.