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

适用于危重患者的新型手臂约束装置，可减少不动、镇静、躁动和认知障碍

• 批准号: 10017805
• 负责人: Dale Murray Needham
• 金额: $ 73.33万
• 依托单位: HEALTHY DESIGN, LTD. CO.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10017805
• 关键词: Agitation; Alzheimer' s Disease; Alzheimer' s disease related dementia; Analgesics; Antipsychotic Agents; Beds; Biomedical Engineering; Biometry; Care given by nurses; Clinical Research; Cognition; Collaborations; Commerce; Critical Care; Critical Illness; Delirium; Dementia; Devices; Effectiveness; Elderly; Enrollment; Enteral Feeding; Equipment; Evaluation; Excision; Exhibits; Family; Family Nursing; Family member; Feedback; Goals; Hand; Hospitals; Immobilization; Impaired cognition; Incidence; Injury; Intensive Care Units; Intervention; Intravenous; Laceration; Lead; Measurement; Measures; Mechanics; Muscle Weakness; Nose; Oral; Outcome; Outcome Measure; Patients; Perception; Pharmaceutical Preparations; Phase; Physical Function; Positioning Attribute; Preparation; Prospective Studies; Qualitative Evaluations; Qualitative Research; Quantitative Evaluations; Randomized Controlled Trials; Recording of previous events; Research; Research Personnel; Resistance; Risk; Risk Factors; Safety; Sedation procedure; Site; Skin; Small Business Technology Transfer Research; Specific qualifier value; Testing; Tube; Upper Extremity; Wrist; actigraphy; arm; base; clinical care; design; endotracheal; experience; high risk; improved; innovation; modifiable risk; mortality; multidisciplinary; novel; older patient; prevent; primary outcome; prospective; prototype; response; restraint; satisfaction; secondary outcome; sedative

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.

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在老年危重病人 机械通气患者，增加活动性;减少躁动，使用镇静药物， 谵妄;并在医院工作人员、家属和患者中表现出高满意度和可接受性。 老年机械通气患者通常用手腕约束固定，以防止自行拔管， 被注射镇静剂以减少由他们的束缚和气管内导管引起的躁动。这种镇静和不动 导致并发症，包括谵妄和肌肉无力，这些都是独立与长期- 长期认知障碍、身体功能下降和死亡率。具体来说，发病率和持续时间 ICU中谵妄的发生率与长期认知障碍密切相关， 类似于阿尔茨海默氏症和相关痴呆症。 Healthy Design正在开发一种新颖的Risksides ™约束装置，它允许手臂活动，但禁止双手 到达口/鼻气管内和喂养管或静脉内管线。因为它允许流动性， Escherosides ™可以减少激动和对镇静剂的需求。在初步的试点测试中， 取得了非常令人鼓舞的成果。该STTR快速通道项目的目标是优化 并在一项随机对照试验（RCT）中对老年重症患者进行评估， 谵妄和相关的长期认知障碍。多学科研究团队拥有专业知识 在重症监护方面，在开展ICU RCT方面具有丰富的经验，并有成功合作的历史。 在第一阶段/目标1期间，将根据先前的反馈对当前的Risksides ™原型进行修改，并在 3例健康受试者。在I期/Aim 2中，将在8例老年机械通气患者中进行前瞻性研究。 患者，以证明1）改良的Risksides ™原型是安全的，2）II期拟定的RCT 是可行的进入第二阶段的里程碑是要证明：1）修改后的RISKSIDES ™约束 在机械通气老年患者中，7个预先规定的安全性标准的平均发生率<5% 需要约束的患者; 2）通过成功招募8名ICU患者进入Aim 2，II期RCT是可行的 并完成至少90%的所有拟议成果措施。 在II期研究中，Aim 3是一项多中心患者内交叉RCT，用于需要进行以下治疗的老年机械通气患者： 将进行约束测试，以测试以下结果：1）在Rissides ™与传统手腕约束： 通过体动计评估活动性（主要结局）; 2）激越、谵妄和药物使用（次要结局 结局）;和3）对器械的满意度和可接受性/感知（次要结局）。 该项目的成功完成将产生一个可用于最终优化的Risksides ™约束， 用于商业化的制剂，并适用于更大规模的临床研究，以证明有效性， 老年ICU患者的长期认知障碍。