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NCT Number: NCT06626217

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

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.

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Key information

Conditions

Perfusion Index

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resting conditions

Other

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

Movement artifacts

Other

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 constriction

Other

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 exercise

Other

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karel Roubik, Prof.

CONTACT

[email protected]

Simon Walzel, MEng.

CONTACT

[email protected]

420724836120

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Registry information

Acronym: PIWATCH

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 3, 2024
Registry last updated: Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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