Effect of Pulse Oximeter Device on Measured Perfusion Index Values

NCT ID: NCT06635018

Last Updated: 2024-10-10

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 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.

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.

Conditions

Perfusion Index

Study Design

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

Study Groups

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).

Group Type: EXPERIMENTAL

Resting conditions

Intervention Type: 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.

Movement artifacts

Intervention Type: 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.

Circulation constriction

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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, Prof.

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_01_2024

Identifier Type: -

Identifier Source: org_study_id