Evaluation of Capillary Refill Index (CRI)

Comparison of a peripheral perfusion assessment method using a pulse oximeter to the conventional capillary refill time visually assessed by a clinician.

Study Overview

• Status: Completed
• Conditions: Perfusion; Complications
• Intervention / Treatment: Device: capillary refill index (CRI)

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults in ED or admitted to ICU

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnant
2. Prisoners
3. Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor
4. Patients' deemed clinically unstable by the clinical team

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive Capability of the Altered Peripheral Perfusion	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.	< 30 min *right after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Device CRI to Conventional (Visual) CRT	Spearman's correlation coefficient to assess the correlation between CRI and CRT values.	< 30 min *right after enrollment

Collaborators and Investigators

• Sponsor: Nihon Kohden
• Investigators: Principal Investigator: Timmy Li, PhD, Admin Dir Clinical Research Emergency Medicine, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Actual): December 4, 2019
• Study Completion (Actual): December 23, 2019

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: peripheral perfusion; capillary refill time
• Other Study ID Numbers: CS-011-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No