Evaluating Wireless Vital Parameter Continuous Monitoring for Critically Ill Patients Hospitalized in Internal Medicine Units: A Pilot Randomized Controlled Trial

Background: Wireless Vital Parameter Continuous Monitoring (WVPCM) allows the continuous tracking of patient physiological parameters, facilitating the earlier detection of clinical deterioration, especially in low-intensity care settings. The aim of this study is to evaluate the effectiveness of using WVPCM compared to the usual monitoring of critically ill patients hospitalized in Internal Medicine wards. An investigation of the attitude of health professionals towards the use of new technologies in daily practice to improve patient management was also carried out. Methods: The LIght Monitor Study (LIMS) is a prospective, open-label, randomized, multi-center pilot trial comparing WVPCM and conventional nurse monitoring during the first 72 h of hospitalization. A central randomization unit used computer-generated tables to allocate patients to two different types of monitoring. The main outcome was the occurrence of major complications. The study planned to enroll 296 critically ill patients with a Modified Early Warning Score (MEWS) ≥ 3 and/or National Early Warning Score (NEWS) ≥ 5 across two Internal Medicine (IM) Units in Italy. The investigation of the attitude of nurses towards the use of WVPCM was carried out by using a questionnaire and a qualitative survey. Results: Due to the COVID-19 outbreak, the study was interrupted early and only 135 patients (WVPCM = 68; standard care = 67) were randomized. One patient in the control group was excluded from analysis because of drop-out, leaving 134 patients for intention to treat analysis. No statistically significant differences between standard care and WVPCM were observed in terms of major complications (37.5%, vs. 31.2% p = 0.475), in-hospital mortality (17.5% vs. 11.1%, p = 0.309), and median hospital length of stay (9 vs. 10 days, p = 0.463). WVPCM decreased nursing workload compared to the control, as the average time spent by nurses on the detection of vital signs per patient was 0 min per patient per day compared to 24.4 min (p < 0.001) observed in the control group. Twenty-two percent of patients in the WVPCM group (15/68) experienced discomfort with the device, resulting in its removal. The investigation of nurses involved 16 out of 18 people participating in the study. Opinions on the wireless device for patient monitoring were particularly favorable; most of them considered remote monitoring clearly superior to traditional in-person visits and easy to use after a brief practice period. All participants recognized the safety benefits of the system. Conclusions: The reduced sample size of this pilot study does not allow us to draw any conclusions on the superiority of WVPCM compared to standard care in terms of clinical outcomes. However, we observed a positive trend in the reduction of major complications.