Measurement of capillary refill time with a handheld prototype device: a comparative validation study in healthy volunteers.

Abstract

Validity and reproducibility of clinical capillary refill time (CRT) measurement depend on many factors in daily routine practice. We conducted a prospective validation study of an automatized handheld prototype device providing standardized CRT assessment (DiCART™) in 20 healthy volunteers. Three different methods of CRT measurement were compared before and during dynamic circulatory changes induced by venous and arterial occlusion tests at both upper and lower limb levels: CRTCLIN corresponding to basic clinical assessment and considered as the reference method; CRTVIDEO corresponding to off-line videos reviewed by investigators recorded by DiCART™; and CRTDiCART corresponding to on-line videos analysed by a built-in proprietary mathematical algorithm included in DiCART™. Five subjects were excluded because of a DiCART™ dysfunction. ROCAUC to detect arterial occlusion test changes at the upper limb level were 1.00 (95%CI 1.00; 1.00), 0.96 (95%CI 0.88; 1.00), and 0.92 (95%CI 0.79; 1.00) for CRTCLIN, CRTVIDEO, and CRTDiCART, respectively. Precision of CRTCLIN and CRTVIDEO were significantly better than CRTDiCART (0.18 and 0.20 vs. 0.28; P < 0.05). Percentages of error were 76% and 87% for CRTVIDEO and CRTDiCART, respectively. DiCART™ had an excellent discrimination to detect major changes in CRT induced by arterial ischemia. However, the perfectible precision, the poor agreement with clinical assessment and numerous device dysfunctions give leads to the development of a further version of the prototype before promoting its use in clinical practice.Trial registration clinicaltrial.gov. Identifier: NCT04538612.