Perfusion IndexPIWATCHNCT06626217
Comparison of Perfusion Index Monitoring Using a Smartwatch and a Pulse Oximeter
A study testing Resting conditions, Movement artifacts and Circulation constriction in people with Perfusion Index, run by Czech Technical University in Prague.
Trial summary
The aim of the study is to experimentally compare measured perfusion index values between smartwatch and a medical grade pulse oximeter in healthy subjects at rest and with and without motion artifacts and during exercise. 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
- 50 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 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 or arm perfusion
- Injuries or diseases of the skin of the fingers and arm
- Any acute phase of any disease
Trial locations and contacts
No sites are listed yet.
Karel Roubik, Prof. contact
About this study
The aim of the study is to experimentally compare measured perfusion index values between smartwatch and a medical grade pulse oximeter in healthy subjects at rest and with and without motion artifacts and during exercise.
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. For example, continuous measurement of the perfusion index has been used to monitor changes in finger blood flow after finger replantation (surgical reattachment of the finger to the patient's body). As the ability to monitor the perfusion index begins to become part of the monitored parameters of smartwatches, this new feature could be used in situations where the use of finger sensors is not appropriate. However, no comparison of perfusion index measurements between smartwatch and pulse oximeter has been made to date.
- Conditions
- Perfusion Index
- Being tested
- Resting conditions, Movement artifacts, Circulation constriction, Physical exercise
- Keywords
- Pulse oximetry, Perfusion index, Finger replantation, Smartwatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting conditionsOther
The volunteers hand is at rest and Perfusion index readings are taken for six minutes from pulse oximeter and smartwatch
Movement artifactsOther
The volunteer periodically spreads his/her fingers and clenches them into a fist, and Perfusion index readings are taken for six minutes from pulse oximeter and smartwatch.
Circulation constrictionOther
The volunteers 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 measurement is repeated three times.
Physical exerciseOther
The volunteer is seated on the exercise bike, rests his forearms on the handlebars and is instructed not to move his arms. The volunteer\'s heart rate is controlled to increase to 120 beats per minute. For five minutes, the perfusion index is recorded from a pulse oximeter and smartwatch.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter | Experimental | Placing the finger pulse oximeter sensor on the left middle finger and placing the Massimo Watch W1 on the volunteer's left wrist (2 cm from the processus styloideus). Four interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction, Physical Exercise). Receives: Other: Resting conditions; Other: Movement artifacts; Other: Circulation constriction; Other: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions.
The comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions (Resting conditions, Movement artifacts, Circulation costriction and Physical exercise) will be analyzed.
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 posted3 Oct 2024
- Study start8 Oct 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, Study chair, Czech Technical University, Fac. of Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626217
- Sponsor's protocol ID
- NVT_02_2024
- Acronym
- PIWATCH
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perfusion Index Monitoring Using a Smartwatch and a Pulse Oximeter
- ClinicalTrials.gov ID
- NCT06626217
- Acronym / sponsor ID
- PIWATCH / NVT_02_2024
- Conditions
- Perfusion Index
- Keywords
- Pulse oximetry, Perfusion index, Finger replantation, Smartwatch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 8 Oct 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 3 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 the study is to experimentally compare measured perfusion index values between smartwatch and a medical grade pulse oximeter in healthy subjects at rest and with and without motion artifacts and during exercise.
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. For example, continuous measurement of the perfusion index has been used to monitor changes in finger blood flow after finger replantation (surgical reattachment of the finger to the patient's body). As the ability to monitor the perfusion index begins to become part of the monitored parameters of smartwatches, this new feature could be used in situations where the use of finger sensors is not appropriate. However, no comparison of perfusion index measurements between smartwatch and pulse oximeter has been made to date.
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 |
|---|---|---|
| Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter | Experimental | Other: Resting conditions, Other: Movement artifacts, Other: Circulation constriction, Other: Physical exercisePlacing the finger pulse oximeter sensor on the left middle finger and placing the Massimo Watch W1 on the volunteer's left wrist (2 cm from the processus styloideus). Four interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction, Physical Exercise). |
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 or arm perfusion
- Injuries or diseases of the skin of the fingers and arm
- 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 volunteers hand is at rest and Perfusion index readings are taken for six minutes from pulse oximeter and smartwatch | Other | Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter |
| Movement artifactsThe volunteer periodically spreads his/her fingers and clenches them into a fist, and Perfusion index readings are taken for six minutes from pulse oximeter and smartwatch. | Other | Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter |
| Circulation constrictionThe volunteers 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 measurement is repeated three times. | Other | Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter |
| Physical exerciseThe volunteer is seated on the exercise bike, rests his forearms on the handlebars and is instructed not to move his arms. The volunteer\'s heart rate is controlled to increase to 120 beats per minute. For five minutes, the perfusion index is recorded from a pulse oximeter and smartwatch. | Other | Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter |
Primary outcome
Comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions.
Time frame: 1 hour
The comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions (Resting conditions, Movement artifacts, Circulation costriction and Physical exercise) will be analyzed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- 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. contact
Karel Roubik study chair
Czech Technical University, Fac. of Biomedical Engineering
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.
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: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Walzel, MEng. (420724836120, walzesim@fbmi.cvut.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions. (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 3 Oct 2024.