Impact of an Ambulatory Monitoring System on Deterioration Detection and Clinical Outcomes in Hospitalised Patients. A Feasibility Randomised Controlled Trial Protocol.

BackgroundDespite the exponential growth of wearable technology, previous research indicates a lack of statistically significant evidence to support the hypothesis that implementation of wearable ambulatory vital sign monitoring systems impact early patient deterioration detection and clinical outcomes. This highlights the need for large, rigorous studies to address this gap. The objective of this feasibility trial is to assess the impact of an ambulatory monitoring system (AMS) on deterioration detection and clinical outcomes in hospitalised patients, compared to standard care. As a secondary objective we will assess the feasibility of conducting a full randomised controlled trial (RCT).MethodsBetween 120 and 240 patients will be recruited and randomised equally to either an AMS or standard care group. Wearable devices will include a pulse oximeter (monitoring pulse rate and oxygen saturation), a chest patch (monitoring heart rate, respiratory rate and temperature) and a wireless blood pressure cuff (monitoring systolic and diastolic blood pressure). Both groups will wear the devices during their ward length of stay, however only data and alerts from the AMS group will be visible to clinical staff.DiscussionRecruitment of participants is expected to start in January 2022, with an anticipated completion date of December 2022. This feasibility RCT will test the early impact of our AMS implementation in a non-intensive care ward and provide data to support the design and deployment of a full RCT which will provide much-needed evidence of the impact of AMS on early deterioration detection and clinical outcomes.