Alvarado Sánchez Jorge Iván, Castillo Morales Laura Maria, Cardenas Bolivar Yenny Rocio, Montañez Nariño Valentina, Stozitzky Ríos Maria Valentina, Arévalo Guerrero Catherine Lissell, Pulido Bobadilla Miguel Leonardo, Melo Rojas Diana Marcela, López Rubio Ana Gabriela, Ortíz Moreno Diana Carolina, Barreto Garzón Paula Andrea, Murillo Marisol, Mora-Salamanca Andrés Felipe
Department of Critical Medicine and Intensive Care, Fundación Santa Fe de Bogotá, Bogotá, Colombia.
Department of Physiology, Faculty of Medicine, Universidad Nacional de Colombia, Bogotá, Colombia.
PLoS One. 2025 May 19;20(5):e0324335. doi: 10.1371/journal.pone.0324335. eCollection 2025.
Intensive care unit-acquired weakness (ICUAW) and post-intensive care syndrome (PICS) are significant complications among critically ill patients, leading to prolonged hospital stays, increased healthcare costs, and reduced quality of life. Early physical therapy in the ICU has shown promise in mitigating these adverse outcomes, yet randomized controlled trials (RCTs) evaluating the combined effects of physical, respiratory, occupational, and speech therapy initiated within the first 24-72 hours are lacking.
This single center, controlled clinical trial aims to establish the efficacy and safety of an early multimodal rehabilitation program (MRP) compared with a late MRP in mechanically ventilated patients admitted to the ICU. Adult patients (≥18 years) with a Barthel score ≥70 and requiring invasive mechanical ventilation for more than 24 hours will be included. Participants will be randomly assigned to early MRP, initiated within 24 hours post-intubation, or late MRP, starting 72 hours post-intubation. The primary outcome is the duration of mechanical ventilation. Safety will be assessed by comparing the number of adverse events between groups. The MRP includes passive and active interventions from physical, speech, respiratory, and occupational therapy teams. Therapy intensity and type are adjusted according to the patient's Richmond Agitation-Sedation Scale (RASS) score. Patients with lower RASS scores (indicating deeper sedation) will receive primarily passive interventions (e.g., passive range-of-motion exercises), while those with higher RASS scores (indicating lighter sedation or alertness) will engage in more active therapies (e.g., active-assisted exercises and functional mobility activities). For patients with RASS ≥2, occupational therapy will focus on behavioral and environmental modulation, employing calming techniques, sensory stimuli, and cognitive tasks, with family education to support spatiotemporal orientation. This adaptive approach ensures patient safety and optimizes therapy based on the patient's current sedation level and clinical condition.
The results will be published in peer-reviewed journals and presented at conferences.
ClinicalTrials.gov NCT06133504. Registered on November 11, 2023.
重症监护病房获得性肌无力（ICUAW）和重症监护后综合征（PICS）是危重症患者的重要并发症，会导致住院时间延长、医疗费用增加和生活质量下降。在重症监护病房（ICU）早期进行物理治疗已显示出减轻这些不良后果的前景，但缺乏评估在最初24 - 72小时内启动的物理、呼吸、职业和言语治疗联合效果的随机对照试验（RCT）。
这项单中心对照临床试验旨在确定与晚期多模式康复计划（MRP）相比，早期多模式康复计划对入住ICU的机械通气患者的疗效和安全性。将纳入Barthel评分≥70且需要有创机械通气超过24小时的成年患者（≥18岁）。参与者将被随机分配到早期MRP组（在插管后24小时内启动）或晚期MRP组（在插管后72小时开始）。主要结局是机械通气时间。通过比较组间不良事件的数量来评估安全性。MRP包括物理、言语、呼吸和职业治疗团队的被动和主动干预。治疗强度和类型根据患者的里士满躁动 - 镇静量表（RASS）评分进行调整。RASS评分较低（表明镇静程度较深）的患者将主要接受被动干预（如被动关节活动度练习），而RASS评分较高（表明镇静程度较轻或清醒）的患者将参与更积极的治疗（如有辅助的主动练习和功能性活动）。对于RASS≥2的患者，职业治疗将侧重于行为和环境调节，采用安抚技巧、感觉刺激和认知任务，并进行家庭教育以支持时空定向。这种适应性方法可确保患者安全，并根据患者当前的镇静水平和临床状况优化治疗。
研究结果将发表在同行评审期刊上，并在会议上展示。
ClinicalTrials.gov NCT06133504。于2023年11月11日注册。
