Effect of Pulse Oximeter Device on Measured Perfusion Index Values (PICOMP)

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.

Study Overview

• Status: Completed
• Conditions: Perfusion Index
• Intervention / Treatment: Other: Resting conditions; Other: Movement artifacts; Other: Circulation constriction

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. It can be used as an indicator of the severity of health status in different groups of critically ill patients, e.g. in patients with sepsis, in patients after cardiac arrest, for early detection of critical heart defects, for indirect assessment of patient pain, as an indicator of fluid therapy and reactivity, or for assessment and evaluation of anaesthesia in the operating room. However, there is currently no standardised calculation of PI and different manufacturers use different algorithms for the calculation. The consequence is that absolute measured values cannot be compared between devices.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Kladno, Czechia, 272 01
    • Czech Technical University in Prague

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 perfusion
• Injuries or diseases of the skin of the fingers
• 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: Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index; 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; 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.; Other: Movement artifacts; 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.; Other: Circulation constriction; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Perfusion index; Pulse oximetry; Nociception during Anesthesia
• Other Study ID Numbers: NVT_01_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