Effect of Pulse Oximeter Device on Measured Perfusion Index Values

NCT06635018 | Completed

• 1 other identifier: NVT_01_2024
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to experimentally determine the effect of pulse oximeters from different manufacturers on measured perfusion index values in healthy subjects at rest and with and without motion artifacts.

Conditions

Perfusion Index

Keywords

Perfusion index; Pulse oximetry; Nociception during Anesthesia

Outcome Measures

Primary Outcomes (1)

• Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction

  Perfusion index values will be measured and compared using pulse oximeters from different manufacturers under various conditions, including resting state, movement artifacts, and circulatory restriction. This evaluation will provide a direct comparison of the variability in perfusion index measurements across devices under each condition.

  1 hour

Study Arms (1)

Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index

EXPERIMENTAL

Three finger pulse oximeter sensors from different manufacturers are placed on the middle fingers of one hand. Three interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction).

Other: Resting conditions; Other: Movement artifacts; Other: Circulation constriction

Interventions

Resting conditions OTHER

The volunteer's hands are at rest and PI readings are taken for six minutes. After two minutes, there is always a randomized rotation of the sensors between the fingers.

Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index

Movement artifacts OTHER

The volunteer periodically spreads his/her fingers and clenches them into a fist, and PI readings are taken for six minutes. After two minutes there is always a randomized rotation of sensors between the fingers.

Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index

Circulation constriction OTHER

The volunteer's 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 sensors are randomly rotated, and the measurement is repeated.

Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index

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 perfusion
• Injuries or diseases of the skin of the fingers
• Any acute phase of any disease

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (1)

Czech Technical University in Prague

Kladno, 272 01, Czechia

Location

Study Officials

• Karel Roubik, Prof.

  Czech Technical University, Fac. of Biomedical Engineering

  STUDY CHAIR

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 10, 2024
• Study Start: February 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: August 30, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

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

Locations

CZ (1)