跳至主要内容
临床试验/NCT05140993
NCT05140993招募中不适用

The Role of Emotional and Orientation Support in Prevention of Postoperative Delirium Among Elderly Surgical Patients - a Multiple-crossover Clinical Trial

Barak Cohen, MD1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Incidence of postoperative delirium

研究概览

简要总结

Postoperative delirium is common and associated with significant adverse outcomes. Its etiology is unknown, and little is known about associated risk factors. The investigatorea aim to test whether providing emotional and orientation support can reduce the risk of postoperative delirium in elderly patients undergoing elective non-cardiac surgery. Specifically, the investigators will test whether allowing such patients to keep their hearing and visual aids and be escorted into the operating room by a family member until anesthesia induction reduces the incidence of postoperative delirium. Delirium will be actively screened as part of our institution's clinical practice starting at PACU admission and for a minimum of 2 postoperative days. The investigators will use a multiple cross-over design to enroll all eligible patients and alternate between the intervention and our common practice (removing sensorial aids in the preoperative area and not allowing patients' escort beyond that point) every 2 weeks for up to 2 years.

详细描述

The world population is constantly growing older, and life expectancy in the western world is well over 80 years. The older population suffers more severe comorbidities, yet needs more surgical care. Anesthesiologists and surgeons are therefore required to care for older and sicker patients, often undergoing longer and more complex procedures than in the past.

Delirium is one of the most common adverse events experienced by hospitalized elderly patients. It is defined as an acute and fluctuating state characterized by altered awareness, behavior, emotional state, or thinking, and is associated with other morbidities as well as with mortality. Postoperative delirium (POD) affects between 10% and 50% of elderly surgical patients, depending on patients' baseline morbidities, the type of surgical procedure, and the tools and criteria used for diagnosis. POD is certainly the most common postoperative complication in this patient population, and is strongly associated with other postoperative adverse outcomes and mortality. Many societies and task-forces now recommend routine screening for cognitive decline and delirium in the perioperative period.

Several risk factors have been identified to be independently associated with POD, such as age, sex, and preoperative cognitive level. Nonetheless, most of the known risk factors are not modifiable, and little is known regarding interventions that can potentially decrease the risk of POD.

The division of Anesthesia and Intensive Care in the Tel-Aviv Medical Center has been conducting a quality improvement project since 2019, in which all surgical patients 70 years or older having elective non-cardiac non-cranial surgery are screened postoperatively for POD using the validated 4A's test starting in the post-anesthesia care unit (PACU) and for at least two postoperative days. The participants are also screened for preoperative cognitive decline, and monitored for other significant postoperative adverse events. Nearly 2000 eligible patients have been analyzed to date.

POD incidence in our institution is over 14%, and the investigators found a strong association between preoperative cognitive decline and POD, as also demonstrated by others. Interestingly, the investigators also demonstrated a strong association between delirium diagnosis in PACU and a later diagnosis in the surgical ward, suggesting that screening for delirium as early as PACU admission is important.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
70 Years 至 120 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age ≥ 70 years
  • •having non-cardiac and non-cranial surgery in the Tel-Aviv Medical Center

排除标准

  • •Known psychiatric or severe neurologic disorder (e.g., Alzheimer's disease, past stroke)
  • •Preoperative cognitive decline (MiniCog test result < 3 points)
  • •Not planned to be extubated and awaken at surgery conclusion
  • •Known inability to cooperate with postoperative delirium screening (language barrier, aphasia)

研究组 & 干预措施

extended support

Experimental

providing extended emotional and orientation support

干预措施: extended emotional and orientation support (Behavioral)

common practice

No Intervention

The hospital routine clinical standard- not providing extended emotional and orientation support

结局指标

主要结局

Incidence of postoperative delirium

时间窗: Up to 30 postoperative days

A composite outcome of postoperative delirium, consisting of at least of the following - a positive 4A's test, positive 3D-CAM test, or delirium symptoms described in the nursing notes.

次要结局

未报告次要终点

研究者

发起方
Barak Cohen, MD
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Barak Cohen, MD

Vice Chair Division of Anesthesiology, Intensive Care Medicine and Pain management, Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel

Tel-Aviv Sourasky Medical Center

研究点 (1)

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