Comparison of Perfusion Index Monitoring Using a Smartwatch and a Pulse Oximeter (PIWATCH)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perfusion Index
• Intervention / Treatment: Other: Resting conditions; Other: Movement artifacts; Other: Circulation constriction; Other: Physical 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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon Walzel, MEng.; Phone Number: 420724836120; Email: walzesim@fbmi.cvut.cz
• Study Contact Backup: Name: Karel Roubik, Prof.; Email: roubik@fbmi.cvut.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter; 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).

Other: Resting conditions; The volunteers hand is at rest and Perfusion index readings are taken for six minutes from pulse oximeter and smartwatch; Other: Movement artifacts; 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.; Other: Circulation constriction; 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.; Other: Physical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Collaborators and Investigators

• Sponsor: Czech Technical University in Prague
• Investigators: Study Chair: Karel Roubik, Czech Technical University, Fac. of Biomedical Engineering

Study record dates

Study Major Dates

• Study Start (Estimated): October 8, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Smartwatch; Perfusion index; Pulse oximetry; Finger replantation
• Other Study ID Numbers: NVT_02_2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
• IPD Sharing Time Frame: Unlimited from the time of processing complete measured data
• IPD Sharing Access Criteria: Publicly available to everyone
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No