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

NCT ID: NCT06626217

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2025-08-30

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.

Conditions

Perfusion Index

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Resting conditions

Intervention Type: OTHER

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

Movement artifacts

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

Resting conditions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Czech Technical University in Prague

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karel Roubik

Role: STUDY_CHAIR

Czech Technical University, Fac. of Biomedical Engineering

Central Contacts

Simon Walzel, MEng.

Role: CONTACT

walzesim@fbmi.cvut.cz

420724836120

Karel Roubik, Prof.

Role: CONTACT

roubik@fbmi.cvut.cz

Other Identifiers

NVT_02_2024

Identifier Type: -

Identifier Source: org_study_id