Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-05 @ 6:05 AM
Study NCT ID:
NCT06635018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-10
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pulse Oximeter Device on Measured Perfusion Index Values
Sponsor:
Czech Technical University in Prague
Organization:
Study Overview
Official Title:
Effect of Pulse Oximeter Device on Measured Perfusion Index Values
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICOMP
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: