An interventional study of Resting conditions and Movement artifacts in Perfusion Index, sponsored by Czech Technical University in Prague. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Czech Technical University in Prague · Not applicable, Interventional, and Diagnostic
The aim of the study is to experimentally compare measured perfusion index values between smartwatch and a medical grade pulse oximeter in healthy subjects at rest and with and without motion artifacts and during exercise.
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. For example, continuous measurement of the perfusion index has been used to monitor changes in finger blood flow after finger replantation (surgical reattachment of the finger to the patient's body). As the ability to monitor the perfusion index begins to become part of the monitored parameters of smartwatches, this new feature could be used in situations where the use of finger sensors is not appropriate. However, no comparison of perfusion index measurements between smartwatch and pulse oximeter has been made to date.
Czech Technical University in Prague is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Placing the finger pulse oximeter sensor on the left middle finger and placing the Massimo Watch W1 on the volunteer's left wrist (2 cm from the processus styloideus). Four interventions subsequently follow (Resting condition, Movement artifacts and Circulation constriction, Physical Exercise).
Other: Resting conditions · Other: Movement artifacts · Other: Circulation constriction · Other: Physical exercise
The volunteers hand is at rest and Perfusion index readings are taken for six minutes from pulse oximeter and smartwatch
The volunteer periodically spreads his/her fingers and clenches them into a fist, and Perfusion index readings are taken for six minutes from pulse oximeter and smartwatch.
The volunteers 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 measurement is repeated three times.
The volunteer is seated on the exercise bike, rests his forearms on the handlebars and is instructed not to move his arms. The volunteer\'s heart rate is controlled to increase to 120 beats per minute. For five minutes, the perfusion index is recorded from a pulse oximeter and smartwatch.
Comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions.
The comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions (Resting conditions, Movement artifacts, Circulation costriction and Physical exercise) will be analyzed.
Time frame: 1 hour
No study locations are listed for this record.
Plan to share: Yes — The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/
Supporting information: Statistical analysis plan
Time frame: Unlimited from the time of processing complete measured data
Access criteria: Publicly available to everyone
Data sharing details ↗ · ventilation.fbmi.cvut.cz
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Apr 2025, 6 months later.
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This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Czech Technical University in Prague