Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT04144166
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Capillary Refill Index
Sponsor:
Nihon Kohden
Organization:
Study Overview
Official Title:
Evaluation of Capillary Refill Index
Status:
COMPLETED
Status Verified Date:
2021-01
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:
CRI
Brief Summary:
Comparison of a peripheral perfusion assessment method using a pulse oximeter to the conventional capillary refill time visually assessed by a clinician.
Detailed Description:
A new technology, capillary refill index (CRI), to assess peripheral perfusion status quantitatively using pulse oximeter waveforms is being developed. The conventional capillary refill time (CRT) is widely used in clinical settings as a gold standard to assess peripheral perfusion.
The objective of this study is to evaluate the capability of CRI to predict altered peripheral perfusion determined with the conventional CRT test. Predictive capability of CRI needs to be assessed to achieve a goal to provide clinicians with an alternative method to the conventional CRT.
The objective of this study is to evaluate the capability of CRI to predict altered peripheral perfusion determined with the conventional CRT test. Predictive capability of CRI needs to be assessed to achieve a goal to provide clinicians with an alternative method to the conventional CRT.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: