Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment

摘要 这个快速通道STTR项目的目标是优化和测试一种新的手臂约束，用于老年危重患者 机械通风，增加患者的活动能力，减少烦躁不安，镇静药物的使用，以及 精神错乱；在医院工作人员、家属和患者中表现出很高的满意度和可接受性。 老年机械通气患者经常使用手腕约束来固定，以防止自我拔管和 使用镇静剂以减少因束缚和气管插管而引起的骚动。这种镇静和静止 导致并发症，包括精神错乱和肌肉无力，这些都与长期的 长期认知障碍、身体功能减退和死亡率。具体地说，发病率和持续时间 ICU中的精神错乱与长期的认知损害密切相关，也就是 类似于阿尔茨海默氏症和相关痴呆症。 健康设计公司正在开发一种新型的Exerside™约束，它允许手臂移动，但禁止手 到达口腔/鼻腔内气管和喂养管或静脉导管。因为它允许机动性， 此外，™可能会减少焦虑和镇静剂的需求。在初步的试点测试中，Exerside™已经 显示了非常令人鼓舞的结果。该STTR快速通道项目的目标是优化 对™进行研究，并在一项随机对照试验中对老年危重患者进行评估。 精神错乱和相关的长期认知障碍。多学科调查员团队拥有专业知识 在重症监护方面，在进行ICU随机对照试验方面有丰富的经验，并有成功合作的历史。 在阶段I/AIM 1期间，将根据先前的反馈修改当前的Exerside™原型，并在 3例健康受试者。在阶段I/AIM 2中，将对8名使用机械通气的老年人进行前瞻性研究 患者证明1)修订的Exerside™原型是安全的，2)第二阶段建议的随机对照试验 是可行的。进入第二阶段的里程碑是证明：1)修订后的Exerside™限制 在7个预先指定的安全标准中，机械通气的老年患者的平均发病率为5% 谁需要约束；以及2)第二阶段的随机对照试验是可行的，成功地将8名ICU患者纳入AIM 2 并至少完成所有拟议结果衡量标准的90%。 在第二阶段，目标3是在需要机械通气的老年患者中进行多部位患者内交叉RCT 将进行约束以测试Exerside™与传统手腕约束的以下结果：1) 活动描记评估活动能力(主要结果)；2)躁动、精神错乱和用药(次要结果) 结果)；以及3)对设备的满意度和可接受性/感知(次要结果)。 该项目的成功完成将导致外部™限制，为最终优化做好准备 为商业化做准备，适合于更大规模的临床研究，以证明有效性降低 老年ICU患者的长期认知损害。

ABSTRACT The goal of this Fast-Track STTR project is to optimize and test a novel arm restraint in older critically ill mechanically ventilated patients that increases mobility; reduces agitation, use of sedative medications, and delirium; and exhibits high satisfaction and acceptability among hospital staff, family members, and patients. Older mechanically ventilated patients are often immobilized with wrist restraints to prevent self-extubation and are sedated to reduce agitation caused by their restraints and endotracheal tube. This sedation and immobility lead to complications, including delirium and muscle weakness, that are independently associated with long- term cognitive impairment, reduced physical functioning, and mortality. Specifically, the incidence and duration of delirium in the ICU are strongly and independently associated with long-term cognitive impairment that is similar to Alzheimer’s Disease and Related Dementias. Healthy Design is developing the novel Exersides™ restraint that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, Exersides™ may reduce agitation and the need for sedatives. In preliminary pilot testing, Exersides™ has demonstrated very encouraging results. The objectives of this STTR Fast-Track project are to optimize Exersides™ and evaluate it in a randomized controlled trial (RCT) in older critically ill patients at high risk for delirium and associated long-term cognitive impairment. The multidisciplinary investigator team has expertise in critical care, extensive experience in conducting ICU RCTs, and a history of successful collaboration. During Phase I/Aim 1, the current Exersides™ prototype will be revised based on prior feedback and tested in 3 healthy subjects. In Phase I/Aim 2, a prospective study will be performed in 8 older mechanically ventilated patients to demonstrate that 1) the revised Exersides™ prototype is safe and 2) the RCT proposed in Phase II is feasible. The milestones to proceed to Phase II are to demonstrate that: 1) the revised Exersides™ restraint has mean incidence rate <5% across 7 pre-specified safety criteria in mechanically ventilated older patients who require restraint; and 2) the RCT in phase II is feasible by successfully enrolling 8 ICU patients into Aim 2 and completing at least 90% of all proposed outcome measures. In Phase II, Aim 3 a multi-site within-patient crossover RCT in older mechanically ventilated patients requiring restraint will be conducted to test the following outcomes in Exersides™ versus traditional wrist restraint: 1) Mobility assessed by actigraphy (primary outcome); 2) Agitation, delirium, and medication use (secondary outcomes); and 3) Satisfaction with and acceptability/perceptions of the device (secondary outcomes). Successful completion of this project will result in an Exersides™ restraint that is ready for final optimzation in preparation for commercization, and is suitable for larger clinical studies to demonstrate effectiveness reducing long-term cognitive impairment in older ICU patients.