Skip to main content
Clinical Trials/NCT04144166
NCT04144166
Completed
Not Applicable

Evaluation of Capillary Refill Index

Nihon Kohden1 site in 1 country60 target enrollmentOctober 29, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perfusion; Complications
Sponsor
Nihon Kohden
Enrollment
60
Locations
1
Primary Endpoint
Predictive Capability of the Altered Peripheral Perfusion
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2019
End Date
December 23, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Individuals 18 years of age or older
  • Patients who present to the ED or who are admitted to the ICU of North Shore University Hospital (NSUH)

Exclusion Criteria

  • Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor
  • Patients' deemed clinically unstable by the clinical team

Outcomes

Primary Outcomes

Predictive Capability of the Altered Peripheral Perfusion

Time Frame: < 30 min *right after enrollment

The area under the curve (AUC) of the receiver operator characteristic (ROC) curve analysis on CRI values to predict probability of altered peripheral perfusion determined with the CRT test.

Secondary Outcomes

  • Correlation of Device CRI to Conventional (Visual) CRT(< 30 min *right after enrollment)

Study Sites (1)

Loading locations...

Similar Trials