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Comparison of Perfusion Index Monitoring Using a Smartwatch and a Pulse Oximeter

Comparison of Perfusion Index Monitoring Using a Smartwatch and a Pulse Oximeter

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06626217
Acronym
PIWATCH
Enrollment
50
Registered
2024-10-03
Start date
2024-10-08
Completion date
2025-08-30
Last updated
2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perfusion Index

Keywords

Pulse oximetry, Perfusion index, Finger replantation, Smartwatch

Brief 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.

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.

Interventions

The volunteers hand is at rest and Perfusion index readings are taken for six minutes from pulse oximeter and smartwatch

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.

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.

OTHERPhysical exercise

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.

Sponsors

Czech Technical University in Prague
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Interventional prospective single-arm study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Healthy Adult Volunteer

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions.1 hourThe 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.

Contacts

Primary ContactSimon Walzel, MEng.
walzesim@fbmi.cvut.cz420724836120
Backup ContactKarel Roubik, Prof.
roubik@fbmi.cvut.cz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026