Godoy-González Marta, López-Aguilar Josefina, Fernández-Gonzalo Sol, Gomà Gemma, Blanch Lluís, Brandi Santiago, Ramírez Sergi, Blasi Joel, Verschure Paul, Rialp Gemma, Roca Miquel, Gili Margalida, Jodar Mercè, Navarra-Ventura Guillem
Critical Care Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí (I3PT-CERCA), Universitat Autònoma de Barcelona, Sabadell, Spain.
Department of Clinical and Health Psychology, Universitat Autònoma de Barcelona, Bellaterra, Spain.
BMC Psychiatry. 2024 Dec 18;24(1):917. doi: 10.1186/s12888-024-06360-4.
Experiencing a critical illness may be a stressful life event that is also associated with cognitive dysfunction during and after the intensive care unit (ICU) stay. A deep-tech solution based on non-immersive virtual reality, gamification and motion capture called Rehabilitation Gaming System for Intensive Care Units (RGS-ICU) has been developed that includes both cognitive stimulation and relaxation protocols specifically designed for patients with critical illness. This study aims to evaluate whether the cognitive and relaxation protocols of the RGS-ICU platform are 1) effective in improving neuropsychological outcomes during and after ICU stay and 2) safe for patients with critical illness.
This is a study protocol for a multicenter longitudinal randomized clinical trial. At least 80 patients with critical illness will be included: 40 experimental subjects and 40 control subjects. Patients in the experimental group will receive daily 20-min sessions of cognitive stimulation and relaxation with the RGS-ICU platform adjuvant to standard ICU care in their own rooms during the ICU stay and until discharge from the ICU or up to a maximum of 28 days after randomization, provided they are alert and calm. Patients in the experimental group will be constantly monitored as part of standard ICU care to ensure the safety of the intervention and that no avoidable adverse events occur. Patients in the control group will receive standard ICU care. The primary outcome is objective cognition 12 months after ICU discharge, assessed with a composite index including measures of attention, working memory, learning/memory, executive function and processing speed. The secondary outcome is the safety of the intervention, assessed by considering the number of sessions terminated early due to unsafe events in physiological parameters. Other outcomes are comfort experienced during the ICU stay, and subjective cognition, mental health (anxiety, depression and post-traumatic stress disorder), functionality and health-related quality of life 12 months after ICU discharge.
The expected results are 1) better neuropsychological outcomes during and after the ICU stay in patients in the experimental group compared to patients in the control group and 2) that the cognitive and relaxation protocols of the RGS-ICU platform are safe for patients with critical illness.
Clinicaltrials.gov NCT06267911. Registered on February 20, 2024.
经历危重病可能是一件压力巨大的生活事件，这也与重症监护病房（ICU）住院期间及之后的认知功能障碍有关。一种基于非沉浸式虚拟现实、游戏化和动作捕捉的深度技术解决方案——重症监护病房康复游戏系统（RGS-ICU）已被开发出来，该系统包括专门为危重病患者设计的认知刺激和放松方案。本研究旨在评估RGS-ICU平台的认知和放松方案是否1）能有效改善ICU住院期间及之后的神经心理学结局，以及2）对危重病患者是否安全。
这是一项多中心纵向随机临床试验的研究方案。将纳入至少80名危重病患者：40名实验组受试者和40名对照组受试者。实验组患者在ICU住院期间直至从ICU出院或随机分组后最多28天内（前提是他们意识清醒且平静），每天在自己房间接受20分钟的认知刺激和放松训练，并使用RGS-ICU平台作为标准ICU护理的辅助手段。作为标准ICU护理的一部分，将持续监测实验组患者，以确保干预措施的安全性且不发生可避免的不良事件。对照组患者将接受标准ICU护理。主要结局是ICU出院12个月后的客观认知，通过一个综合指数进行评估，该指数包括注意力、工作记忆、学习/记忆、执行功能和处理速度等指标。次要结局是干预措施的安全性，通过考虑因生理参数不安全事件而提前终止的训练次数来评估。其他结局包括ICU住院期间的舒适度，以及ICU出院12个月后的主观认知、心理健康（焦虑、抑郁和创伤后应激障碍）、功能状态和健康相关生活质量。
预期结果是1）与对照组患者相比，实验组患者在ICU住院期间及之后有更好的神经心理学结局，以及2）RGS-ICU平台的认知和放松方案对危重病患者是安全的。
Clinicaltrials.gov NCT06267911。于2024年2月20日注册。
