Objective: Chronic limb threatening ischemia is the final stage of peripheral arterial disease. Current treatment is based on revascularization to preserve the leg. In the older, hospitalized chronic limb threatening ischemia patient, delirium is a frequent and severe complication after revascularization. Delirium leads to an increased length of hospital stay, a higher mortality rate and a decrease in quality of life. Currently, no specific guidelines to prevent delirium in chronic limb threatening ischemia patients exist. We aim to evaluate the effect of a multicomponent, multidisciplinary prehabilitation program on the incidence of delirium in chronic limb threatening ischemia patients ≥ 65 years.
Design: A prospective observational cohort study to investigate the effects of the program on the incidence of delirium will be performed in a large teaching hospital in the Netherlands. This manuscript describes the design of the study and the content of this specific prehabilitation program.
Methods: Chronic limb threatening ischemia patients ≥ 65 years that require revascularization will participate in the program. This program focuses on optimizing the patient’s overall health and includes delirium risk assessment, nutritional optimization, home-based physical therapy, iron infusion in case of anaemia and a comprehensive geriatric assessment in case of frailty. The primary outcome is the incidence of delirium. Secondary outcomes include quality of life, amputation-free survival, length of hospital stay and mortality. Exclusion criteria are the requirement of acute treatment or patients who are mentally incompetent to understand the procedures of the study or to complete questionnaires. A historical cohort from the same hospital is used as a control group.
Discussion: This study will clarify the effect of a prehabilitation program on delirium incidence in chronic limb threatening ischemia patients. New insights will be obtained on optimizing a patient’s preoperative mental and physical condition to prevent postoperative complications, including delirium.
Trial: This protocol is registered at the Netherlands National Trial Register (NTR) number: NL9380.

Keywords: chronic limb threatening ischemia, vascular surgical procedures, delirium, delirium/prevention and control, prehabilitation


中文翻译：

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多组分康复作为预防老年慢性肢体缺血患者谵妄的新策略：一项研究方案

目的：慢性肢体威胁性缺血是外周动脉疾病的最后阶段。目前的治疗基于血运重建以保留腿部。对于老年住院的慢性肢体威胁性缺血患者，谵妄是血运重建后常见且严重的并发症。谵妄会导致住院时间延长、死亡率升高和生活质量下降。目前，尚无预防慢性肢体威胁性缺血患者发生谵妄的具体指南。我们的目的是评估多组成部分、多学科预康复计划对≥ 65 岁慢性肢体威胁性缺血患者谵妄发生率的影响。
设计：一项前瞻性观察队列研究将在荷兰的一家大型教学医院进行，以调查该计划对谵妄发生率的影响。本手稿描述了该研究的设计以及该特定预康复计划的内容。
方法：年龄≥65岁、需要血运重建的慢性肢体威胁性缺血患者将参加该计划。该计划的重点是优化患者的整体健康状况，包括谵妄风险评估、营养优化、家庭物理治疗、贫血情况下的铁剂输注以及虚弱情况下的全面老年评估。主要结局是谵妄的发生率。次要结局包括生活质量、无截肢生存率、住院时间和死亡率。排除标准是需要紧急治疗或精神上无法理解研究程序或完成调查问卷的患者。来自同一医院的历史队列被用作对照组。
讨论：本研究将阐明预康复计划对慢性肢体威胁性缺血患者谵妄发生率的影响。将获得关于优化患者术前精神和身体状况以预防术后并发症（包括谵妄）的新见解。
试验：该方案已在荷兰国家试验登记册 (NTR) 注册，编号：NL9380。

关键词：慢性肢体威胁性缺血、血管外科手术、谵妄、谵妄/预防和控制、预康复