Evaluation of Capillary Refill Index

NCT04144166 | Completed Results FDA Device

• 1 other identifier: CS-011-004
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perfusion; Complications

Keywords

capillary refill time; peripheral perfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of Device CRI to Conventional (Visual) CRT

  < 30 min *right after enrollment

Interventions

capillary refill index (CRI) DEVICE

a waveform analysis method using a pulse oximeter to assess peripheral perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults in ED or admitted to ICU

You may qualify if:

• 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)

You may not qualify if:

• Pregnant
• Prisoners
• 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

Sponsors & Collaborators

• Nihon Kohden: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Limitations and Caveats

Sample size: Number of required sample size was 54. Detail of the sample size calculation is described in the clinical protocol document. Actual results were 57 subjects, so results are statistically valid with respect to sample size. Participant flow: Subject discovered to be pregnant and removed from study. Since study is non-invasive and minimal risk, subject and fetus were not exposed to any additional risks. Hospital IRB was notified of deviation and did not require other reporting.

Results Point of Contact

• Title: Director of Clinical Research for Emergency Medicine
• Organization: North Shore University Hospital

TLi2@northwell.edu

(516) 562-1513

Study Officials

• Timmy Li, PhD

  Admin Dir Clinical Research Emergency Medicine, Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: October 29, 2019
• Primary Completion: December 4, 2019
• Study Completion: December 23, 2019
• Last Updated: February 2, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)