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临床试验/NCT05936944
NCT05936944已完成不适用

Ruolo Della Luce Naturale Nella Prevenzione Del Delirium Dopo Cardiochirurgia: Studio Osservazionale Prospettico Con Controllo Storico

Azienda Ospedaliero-Universitaria di Parma1 个研究点 分布在 1 个国家目标入组 448 人开始时间: 2023年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
448
试验地点
1
主要终点
Postoperative delirium

研究概览

简要总结

Postoperative delirium is a common complication that usually occurs acutely within the first 24 hours after surgery and resolves within 72 hours; it is common in all medical areas and particularly affects patients over the age of 65 and those with pre-existing cognitive impairments. It is characterized by difficulty organizing and coordinating thoughts and by slowing down motor functions that are observed for a short period after surgery.

The study will be an observational prospective study with historical control (pre/post-study) whose primary objective is to identify the incidence of postoperative delirium in patients undergoing cardiac surgery. The population will be adult patients undergoing cardiac surgery at our University Hospital over a period of 12 months. The intervention will be exposure to totally artificial light (for patients hospitalized after the relocation of the department to its original location). The comparator will be exposure to natural light (for patients who will be hospitalized during our temporary transfer to an environment with natural lighting). The outcome will be the incidence of delirium, measured with the Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale; episodes of agitation requiring sedative drugs; time elapsed before onset of delirium. The study will last 12 months.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • planned cardiac surgery
  • planned ICU admission after surgery

排除标准

  • cardiac surgery with total suspension of cerebral perfusion
  • patient with diagnosed dementia or major depressive disorder
  • patient unable to perform CAM-ICU evaluation
  • emergent surgery
  • patient in ICU before surgery

结局指标

主要结局

Postoperative delirium

时间窗: first five postoperative days or ICU discharge (wichever comes first)

Occurrence of delirium, diagnosed with at least one positive CAM-ICU evaluation

次要结局

  • Postoperative episodes of agitation(first five postoperative days or ICU discharge (wichever comes first))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Davide Nicolotti

Principal Investigator

Azienda Ospedaliero-Universitaria di Parma

研究点 (1)

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