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

NCT06626217 | Not Yet Recruiting

• 1 other identifier: NVT_02_2024
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perfusion Index

Keywords

Pulse oximetry; Perfusion index; Finger replantation; Smartwatch

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter

EXPERIMENTAL

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; Other: Movement artifacts; Other: Circulation constriction; Other: Physical exercise

Interventions

Resting conditions OTHER

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

Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter

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.

Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter

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.

Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter

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.

Comparison of perfusion index monitoring using a smartwatch and a pulse oximeter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Adult Volunteer

You may not qualify if:

• 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

Sponsors & Collaborators

• Czech Technical University in Prague: lead

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karel Roubik

  Czech Technical University, Fac. of Biomedical Engineering

  STUDY CHAIR

Central Study Contacts

Simon Walzel, MEng.

CONTACT

420724836120; walzesim@fbmi.cvut.cz

Karel Roubik, Prof.

CONTACT

roubik@fbmi.cvut.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional prospective single-arm study

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: October 8, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 30, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Unlimited from the time of processing complete measured data
• Access Criteria: Publicly available to everyone