Evaluation of Capillary Refill Index

Perfusion; Complications Clinical Trial

— CRI  

Official title:

Evaluation of Capillary Refill Index

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144166
• Other study ID #: CS-011-004
• Status: Completed
• Start date: October 29, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: January 2021
• Source: Nihon Kohden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 23, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perfusion; Complications

Intervention

Device:
• capillary refill index (CRI)
a waveform analysis method using a pulse oximeter to assess peripheral perfusion

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nihon Kohden

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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