Evaluation of Capillary Refill Index

Completed

• Conditions: Perfusion; Complications

• Registration Number: NCT04144166
• Lead Sponsor: Nihon Kohden

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.

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study Start: 2019-10-29
• Study First Posted: 2019-10-30
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-23
• Results First Submitted: 2020-11-19
• Status Verified: 2021-01
• Results First Submitted QC: 2021-02-01
• Last Update Submitted: 2021-02-01
• Results First Posted: 2021-02-02
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive Capability of the Altered Peripheral Perfusion	< 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 Outcome Measures

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

Trial Locations

Locations (1)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States