NCT06635018

Effect of Pulse Oximeter Device on Measured Perfusion Index Values

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Czech Technical University in Prague · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-10-30
• Completion: 2025-08-30
• First posted: 2024-10-10
• Last updated: 2026-03-11

Locations

1 site across 1 country: Czechia