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

Czech Technical University in Prague

Status: Not yet enrolling

Conditions: Perfusion Index

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06635018

NVT_01_2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

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

Experimental group

Description:

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).

Treatment:

Other: Circulation constriction

Other: Movement artifacts

Other: Resting conditions