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Effect of Pulse Oximeter Device on Measured Perfusion Index Values

Effect of Pulse Oximeter Device on Measured Perfusion Index Values

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06635018
Acronym
PICOMP
Enrollment
42
Registered
2024-10-10
Start date
2024-02-01
Completion date
2025-08-30
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perfusion Index

Keywords

Perfusion index, Pulse oximetry, Nociception during Anesthesia

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.

Interventions

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.

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.

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.

Sponsors

Czech Technical University in Prague
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Interventional prospective single-arm study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction1 hourPerfusion 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.

Countries

Czechia

Contacts

STUDY_CHAIRKarel Roubik, Prof.

Czech Technical University, Fac. of Biomedical Engineering

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026