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

Not Applicable

Not yet recruiting

• Conditions: Perfusion Index

• Registration Number: NCT06626217
• Lead Sponsor: Czech Technical University in Prague

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03
• Study Start: 2024-10-08
• Primary Completion: 2025-04-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions.	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.