Capillary Refill Index with Rewarming (CRI)

December 21, 2024 updated by: Nihon Kohden

Capillary Refill Index Measurement with a Temperature Control Procedure

A new technology, capillary refill index (CRI) can be useful for assessing peripheral perfusion status quantitatively, but this value can be influenced by fingertip temperature. The aim of this study is to evaluate the predictive accuracy of CRI after a temperature control (warming) procedure in predicting 30-day mortality among ICU/CCU patients. The investigators hypothesized that lowered fingertip temperature can lead prolonged CRI values which are considered as false positives in detection of high-risk patients for mortality, because it causes poor peripheral perfusion which does not reflect hemodynamic instability. The investigators will use the warming procedure to remove or reduce the effect of the fingertip temperature on the CRI measurement and will analyze whether it contributes to reduction of false positives in detection of high-risk patients for mortality.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Capillary refill time (CRT) test is a simple and noninvasive method typically used to assess peripheral blood perfusion at the bedside. CRT is defined as the time required for a distal capillary bed (e.g., fingertip) to regain its color after having received enough compression to cause blanching [1]. Because a prolonged CRT suggests a decrease in peripheral perfusion and poor peripheral perfusion is strongly associated with patients' mortality, several studies reported the clinical usefulness of CRT for predicting patients' mortality in the critical care setting [2,3]. However, because the conventional CRT test depends on clinicians' subjective visual assessment, the inter-rater agreement of it has been questioned, and substantial clinical experience is needed to acquire the reliable skill to measure CRT [4, 5, 6, 7]. Therefore, there is great demand for the creation of objective methods to easily assess peripheral blood perfusion.

Previously, the investigators developed a new mechanical device by using pulse oximetry waveforms, which can enable us to measure CRT easily and objectively. The measurement obtained with this device is called Capillary Refill Index (CRI) to differentiate it from traditional visual assessment of CRT [8]. The method calculates the time it takes for blood to return to the fingertip after release from compression by algorithmically analyzing the light intensity waveform of a normal pulse oximeter sensor attached to a patient's fingertip. The investigators' previous study showed that CRI can be an alternative to traditional CRT for assessing peripheral blood perfusion [8, 9, 10].

In the investigators previous study with healthy volunteer subjects [11], the investigators found that lowered fingertip temperature is a critical component that affects measurement values of CRI, which is the same phenomena with the traditional CRT. Since lowered skin temperature causes poor peripheral perfusion, the patients with lower fingertip temperature can show prolonged CRI without reflecting hemodynamic instability, which means lower skin temperature can increase false positives when using CRI to detect patients at high risk for mortality. The investigators hypothesize that the predictive accuracy of CRI for detecting patients at increased risk for mortality may be improved if the patients' skin temperature is warmed up before the measurement.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult intensive care unit (ICU) patients (both males and females without regards to ethnic and racial backgrounds)

Description

Inclusion Criteria:

  • 18 years of age or older;
  • Admitted to any ICU of North Shore University Hospital (NSUH) within 24 hours

Exclusion Criteria:

  • Pregnant
  • Prisoners
  • Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor
  • Patients who are not deemed clinically stable by the clinical team
  • Wearing nail polish, nail gel, or nail decorations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
capillary refill index (CRI)
a waveform analysis method using a pulse oximeter to assess peripheral perfusion
Device: capillary refill index
a waveform analysis method using a pulse oximeter to assess peripheral perfusion
Other Names:
  • CRI
Procedure: rewarming
warming fingertip skin temperature using an instant hot pack

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC of ROC curve for 30 days mortality
Time Frame: 31 days
Receiver operator characteristic (ROC) curve analysis of CRI after the temperature control procedure for 30 days mortality of ICU patients will be performed and area under the curve (AUC) will be calculated.
31 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon Kohden

Investigators

  • Principal Investigator: Timmy Li, PhD, Administrative Director Clinical Research Emergency Medicine, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 21, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A960-055244
  • 20-0310 (Other Identifier: North Shore-Long Island Jewish Health System)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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