Warmbein Angelika, Schroeder Ines, Mehler-Klamt Amrei, Rathgeber Ivanka, Huber Jana, Scharf Christina, Hübner Lucas, Gutmann Marcus, Biebl Johanna, Lorenz Andreas, Kraft Eduard, Zoller Michael, Eberl Inge, Fischer Uli
Clinical Nursing Research and Quality Management Unit, University Hospital LMU Munich, Marchioninistr. 15, 81377, Munich, Germany.
Department of Anaesthesiology, University Hospital LMU Munich, Marchioninistr. 15, 81377, Munich, Germany.
Pilot Feasibility Stud. 2022 Nov 5;8(1):236. doi: 10.1186/s40814-022-01191-0.
Early mobilization positively influences the outcome of critically ill patients, yet in 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 and the general feasibility of implementing robotic assistance for mobilization in intensive care as well as the effects on patient outcomes as a secondary outcome.
The study is single-centric, prospective, and interventional and follows a longitudinal study design. To evaluate the feasibility of robotic-assisted early mobilization, the number of patients included, the number of performed VEM (very early mobilization) sessions, and 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.
The study will provide information about patient outcomes, feasibility, and the experience of mobilizing professionals. It will show whether robotic systems can increase the 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 min.
ClinicalTrials.gov, NCT05071248 . Date: 2021/10/21.
早期活动对危重症患者的预后有积极影响，但在临床实践中，实施有时具有挑战性。在本研究中，将使用一种自适应机器人辅助系统用于重症监护病房的早期活动。该研究旨在评估活动专业人员的体验、在重症监护中实施机器人辅助活动的总体可行性以及作为次要结果对患者预后的影响。
该研究为单中心、前瞻性、干预性研究，采用纵向研究设计。为评估机器人辅助早期活动的可行性，将收集纳入患者的数量、进行的极早期活动（VEM）次数以及不良事件的数量和类型。在实施前、实施后不久及常规情况下，将使用标准化观察（n>90）和情景访谈（n>36）来评估活动专业人员的行为和体验。将测量患者的预后指标，如机械通气时间、肌肉量丢失和身体活动情况，并与历史患者群体进行比较。约30名患者将被纳入研究。
该研究将提供有关患者预后、可行性以及活动专业人员体验的信息。它将表明机器人系统是否能提高危重症患者的早期活动频率。在重症监护病房的架构内，早期活动作为一种治疗方法可能会受到更多关注。将评估对活动专业人员的影响，如积极性提高、身体负担减轻或压力情况。此外，本研究将关注当前的架构是否允许遵循每天为患者进行两次至少20分钟活动的建议。
ClinicalTrials.gov，NCT05071248。日期：2021年10月21日。
