Continuous Versus Intermittent Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot Cluster Randomized Controlled Trial

Abstract

BackgroundVital signs monitoring is a universal tool for the detection of postoperative complications; however, unwell patients can be missed between traditional observation rounds. New remote monitoring technologies promise to convey the benefits of continuous monitoring to patients in general wards.ObjectiveThe aim of this pilot study was to evaluate whether continuous remote vital signs monitoring is a practical and acceptable way of monitoring surgical patients and to optimize the delivery of a definitive trial.MethodsWe performed a prospective, cluster-randomized, parallel-group, unblinded, controlled pilot study. Patients admitted to 2 surgical wards at a large tertiary hospital received either continuous and intermittent vital signs monitoring or intermittent monitoring alone using an early warning score system. Continuous monitoring was provided by a wireless patch, worn on the patient’s chest, with data transmitted wirelessly every 2 minutes to a central monitoring station or a mobile device carried by the patient’s nurse. The primary outcome measure was time to administration of antibiotics in sepsis. The secondary outcome measures included the length of hospital stay, 30-day readmission rate, mortality, and patient acceptability.ResultsOverall, 226 patients were randomized between January and June 2017. Of 226 patients, 140 were randomized to continuous remote monitoring and 86 to intermittent monitoring alone. On average, patients receiving continuous monitoring were administered antibiotics faster after evidence of sepsis (626 minutes, n=22, 95% CI 431.7-820.3 minutes vs 1012.8 minutes, n=12, 95% CI 425.0-1600.6 minutes), had a shorter average length of hospital stay (13.3 days, 95% CI 11.3-15.3 days vs 14.6 days, 95% CI 11.5-17.7 days), and were less likely to require readmission within 30 days of discharge (11.4%, 95% CI 6.16-16.7 vs 20.9%, 95% CI 12.3-29.5). Wide CIs suggest these differences are not statistically significant. Patients found the monitoring device to be acceptable in terms of comfort and perceived an enhanced sense of safety, despite 24% discontinuing the intervention early.ConclusionsRemote continuous vital signs monitoring on surgical wards is practical and acceptable to patients. Large, well-controlled studies in high-risk populations are required to determine whether the observed trends translate into a significant benefit for continuous over intermittent monitoring.Trial RegistrationInternational Standard Randomised Controlled Trial Number ISRCTN60999823; http://www.isrctn.com /ISRCTN60999823 (Archived by WebCite at http://www.webcitation.org/73ikP6OQz)

Perioperative telemonitoring of older adults with cancer: Can we connect them all?

“…The interest in remote care delivery by eHealth has increased even more during the current COVID-19 pandemic, as remote consultation decreases the risk of spreading the virus and could decrease the pressure on health care resources [9,10]. Additionally, eHealth is used to remotely monitor patients' postoperative recovery in surgical wards or at home after hospital discharge [11,12]. This so-called telemonitoring could contribute to timely detection of postoperative complications and therefore potentially decrease the impact of these complications in frail older patients with cancer [13].…”

Cost utility analysis of continuous and intermittent versus intermittent vital signs monitoring in patients admitted to surgical wards

“…However this rate was changed within the sensitivity analyses. Hospital readmission rates, ICU admission rates and LoS in hospital were obtained from Downey et al 8 while LoS in ICU was obtained from hospital episode statistics (HES) data (NHS digital 2018-19). The applicability of these studies was discussed with the clinical team; after considering the patient population, setting and intervention, a consensus was reached that the selected input values were appropriate for use in the model.…”

“…A recent pilot cluster randomized control trial 8 evaluated the use of a wearable wireless patch for patients admitted to two surgical wards. Although the wide confidence intervals (CI) suggest no statistically significant findings, the results were promising; patients in the continuous monitoring group were administered antibiotics sooner after evidence of sepsis, had a shorter average LoS, and were less likely to require readmission to hospital within 30 days of discharge 8 .…”

Design of the Pilot, Proof of Concept REMOTE-COVID Trial: Remote Monitoring Use in Suspected Cases of COVID-19 (SARS-CoV 2) A Trial Protocol

“…8 Previous studies have demonstrated acceptability and practicability of continuous monitoring using wearable sensors on general surgical and medical wards in the UK and The Netherlands. 9,10 Initial work by Downey et al were limited by imbalanced randomisation leading to signi cant baseline differences across the two trial arms and failure to adjust for these in their analyses. 9 Nevertheless, the wearable sensor seemed to demonstrate feasibility in hospital settings.…”

“…9,10 Initial work by Downey et al were limited by imbalanced randomisation leading to signi cant baseline differences across the two trial arms and failure to adjust for these in their analyses. 9 Nevertheless, the wearable sensor seemed to demonstrate feasibility in hospital settings. Qualitative analyses, through semistructured interviews for patients and healthcare staff, similarly favoured continuous the notion of continuous vital sign monitoring in general wards.…”