Effect of Pulse Oximeter Device on Measured Perfusion Index Values

Not Applicable

Not yet recruiting

• Conditions: Perfusion Index
• Interventions: Other: Resting conditions; Other: Movement artifacts; Other: Circulation constriction

• Registration Number: NCT06635018
• Lead Sponsor: Czech Technical University in Prague

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-01
• Study Start: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-04-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index	Resting conditions	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).
Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index	Movement artifacts	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).
Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index	Circulation constriction	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).

Primary Outcome Measures

Name	Time	Method
Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction	1 hour	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.