Czech Technical University in Prague
Kladno, 272 01, Czechia
NCT Number: NCT06635018
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kladno, 272 01, Czechia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Czech Technical University in Prague
Other
Acronym: PICOMP
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