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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Determination of effect of pulse oximeters from different manufacturers on measured Perfusion index | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resting conditions | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction | 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. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karel Roubik, Prof. | Czech Technical University, Fac. of Biomedical Engineering | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Czech Technical University in Prague | Kladno | 272 01 | Czechia |
The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
Unlimited from the time of processing complete measured data
Publicly available to everyone
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Interventional prospective single-arm study
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| Movement artifacts | Other | 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. |
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| Circulation constriction | Other | 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. |
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