Evaluation of effects of robot-assisted early mobilization on critically ill patients, on the mobilization behaviour and experience of the mobilizing professionals and the organizational processes in an intensive care unit - a clinical intervention study: study protocol

Abstract Background: Early mobilization positively influences the outcome of critically ill patients, yet in the clinical practice the implementation is sometimes challenging. In this study, an adaptive robotic assistance system will be used for early mobilization in intensive care units. The study aims to evaluate the experience of the mobilizing professionals, the effects on patient outcomes, and the general feasibility of implementing robotic assistance for mobilization in intensive care.Methods: The study is monocentric, prospective, interventional, and has multiple time points for data collection. To evaluate the feasibility of robotic-assisted early mobilization, the number of patients included, the number of performed VEM (very early mobilization) sessions, as well as the number and type of adverse events will be collected. The behavior and experience of mobilizing professionals will be evaluated using standardized observations (n>90) and episodic interviews (n>36) before implementation, shortly after, and in routine. Patient outcomes such as duration of mechanical ventilation, loss of muscle mass and physical activity will be measured and compared with a historical patient population. Approximately 30 patients will be included. Discussion: The study will provide information about patient outcomes, feasibility, and the experience of mobilizing professionals. It will show whether robotic systems can increase early mobilization frequency of critically ill patients. Within ICU structures, early mobilization as therapy could become more of a focus. Effects on the mobilizing professionals such as increased motivation, physical relief, or stress will be evaluated. In addition, this study will focus on whether current structures allow following the recommendation of mobilizing patients twice a day for at least 20 minutes. The aim of this study is to evaluate the implementation of a new standard of robotic-assisted early mobilization in the intensive care setting and whether it can be utilized permanently within the current framework.Trial registration: (clinicaltrials.org TRN: NCT05071248, Date: 2021/10/21) URL https://clinicaltrials.gov/ct2/show/NCT05071248