Resumo

ALDAMA FIGUEROA, Alfredo et al. Evaluación clínica del pletismógrafo digital ANGIODIN PD 3000: estudio fase II. Rev Cubana Invest Bioméd [online]. 2001, vol.20, n.4, pp. 279-286. ISSN 1561-3011.

A phase II, monocentric, open and controlled clinical trial was conducted to evaluate the efficiency of the ANGIODIN PD 3000 digital plethysmograph with the utilization of UOANGIO-01 as a comparison pattern. The plethysmographic wave was recorded to diagnose peripheral arterial insufficiency and plantar macroangiopathies and to establish the optimal amputation level. The coincidence of diagnoses between the equipments was determined. The quality and safety of the new apparatus were evaluated. 54 patients were included and 288 evaluative measurements were obtained for analyzing efficacy. There was 96.2 % of coincidence between the diagnoses obtained with the equipments. A sensitivity of 0.953, a specificity of 0.986 and an almost perfect concordance (kappa>0.8) were attained. No adverse events were observed. The new apparatus proved to have better quality than the pattern and to be efficient for diagnosing vascular diseases, which allowed its registration to be used in the clinical practice

Palavras-chave : CLINICAL TRIALS, PHASE II; MEASUREMENT EQUIPMENT; EQUIPMENT AND SUPPLIES; PERIPHERAL VASCULAR DISEASES [diagnosis]; PHOTOPLETHYSMOGRAPHY; AMPUTATION; HEMODYNAMICS.

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