NCT04144166: CRI

Evaluation of Capillary Refill Index

Completed Results posted Last updated 2 February 2021

What this trial tests

trial testing capillary refill index (CRI) in Perfusion; Complications in 60 participants. Completed in 23 December 2019.

Timeline

29 October 2019

Primary endpoint
4 December 2019

23 December 2019

Quick facts

Lead sponsor	Nihon Kohden
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	29 October 2019
Primary completion	4 December 2019
Estimated completion	23 December 2019
Sites	1 location across United States

Drugs / interventions tested

• capillary refill index (CRI)

Conditions studied

• Perfusion; Complications — all drugs for Perfusion; Complications →

Sponsor

Nihon Kohden — full company profile →

Who can join

18 and older, any sex, with Perfusion; Complications. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Predictive Capability of the Altered Peripheral Perfusion Primary · < 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.

Optimal CRI (3.37 s) low peripheral perfusion sensitivity

Group	Value	95% CI
Sensitivity and Specificity to Predict Low Peripheral Perfusion	0.89	0.71 – 0.98

Optimal CRI (3.37 s) low peripheral perfusion specificity

Group	Value	95% CI
Sensitivity and Specificity to Predict Low Peripheral Perfusion	1.00	0.88 – 1.00

Optimal CRI (3.37 s) very low peripheral perfusion sensitivity

Group	Value	95% CI
Sensitivity and Specificity to Predict Low Peripheral Perfusion	0.94	0.73 – 1.00

Optimal CRI (3.37 s) very low peripheral perfusion specificity

Group	Value	95% CI
Sensitivity and Specificity to Predict Low Peripheral Perfusion	0.82	0.67 – 0.93

AUC low peripheral perfusion (> 2 s)

Group	Value	95% CI
Sensitivity and Specificity to Predict Low Peripheral Perfusion	0.986	0.944 – 0.997

AUC very low peripheral perfusion (> 3 s)

Group	Value	95% CI
Sensitivity and Specificity to Predict Low Peripheral Perfusion	0.910	0.807 – 0.960

Correlation of Device CRI to Conventional (Visual) CRT Secondary · < 30 min *right after enrollment

Spearman's correlation coefficient to assess the correlation between CRI and CRT values.

Group	Value	95% CI
Correlation Between CRI and CRT Values	0.866	0.782 – 0.919

Independence of Age Impact on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds) Secondary · < 30 min *right after enrollment

Demonstrate that age is not a variant for CRI measurement

Group	Value	95% CI
All Subject >= 60 Years	0.992	0.888 – 1.000
All Subjects < 60 Years	0.982	0.901 – 1.000

Independence of Fitzpatrick Skin Tone Score on CRI Measurement for Low Peripheral Perfusion (CRT > 2 Seconds) Secondary · < 30 min *right after enrollment

Demonstrate that skin tone is not a variant for CRI measurement

Group	Value	95% CI
All Subjects With Fitzpatrick Skin Tone Score of 1, 2 or 3	0.994	0.993 – 1.00
All Subjects With Fitzpatrick Skin Tone Score of 4, 5 or 6	0.981	0.820 – 0.998

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.