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临床试验/NCT06403410
NCT06403410尚未招募不适用

Evaluation of the Effectiveness of Delirium Prevention Guideline Utilization for Intensive Care Patients

Istanbul Demiroglu Bilim University2 个研究点 分布在 2 个国家目标入组 160 人开始时间: 2024年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
2
主要终点
In patients receiving Delirium Prevention Guidelines, the rate of delirium development is change compared to the control group at the end of one week.

研究概览

简要总结

Delirium is a complication characterized by fluctuations in orientation, memory, thinking, or behavior, with sudden onset of these changes. Studies have shown that pharmacological agents are the most significant risk factors for delirium in intensive care units. In recent years, the impact of non-pharmacological interventions in preventing delirium development has started to be discussed.

详细描述

Delirium is a complication characterized by fluctuations in orientation, memory, thinking, or behavior, with a sudden onset of these changes. Increased mortality and prolonged hospital stay have been identified in patients diagnosed with delirium. Advanced age, underlying urinary or respiratory tract infection, and existing cognitive impairment increase the risk of delirium development. Studies have shown that pharmacological agents are the most significant risk factors for delirium in intensive care units. However, environmental factors such as sound, continuous light, odors, invasive and non-invasive interventions, sensory overload, lack of meaningful verbal and cognitive stimuli, social isolation, immobilization, sleep disorders, temperature, drafts, and absence of windows in the environment are also indicated to contribute to delirium development. The presence of tubes, urinary catheters, invasive procedures, mechanical ventilation, and retention in the patient also increases the risk. In treatment, early detection and prevention of risk factors are prioritized. In case of development, efforts are made to prevent delirium-related complications and reduce its duration through pharmacological and non-pharmacological interventions. However, although many studies have been conducted on the prevention of delirium development with numerous pharmacological agents, a clear conclusion has not yet been reached. Pharmacological agents are generally used to alleviate symptoms. In recent years, the impact of non-pharmacological interventions in preventing delirium development has started to be discussed. Non-pharmacological interventions used in delirium prevention, as published by the National Institute for Health and Care Excellence (NICE), are itemized as pain management, prevention of dehydration, early mobilization, infection control, regulation of medications, sleep hygiene, and patient orientation. NICE also emphasizes the necessity of using a validated tool for assessing delirium.

A meta-analysis study has been published examining non-pharmacological interventions aimed at reducing the incidence of delirium, with a total of 26 studies included. According to this study, the methods that reduce the incidence are, respectively; family involvement, exercise program, multiple interventions (occupational therapy, reorientation, sleep therapy, music, etc.), ensuring cerebral hemodynamics, arranging the physical environment, and applying a sedation protocol. When the studies are examined, it is seen that efforts focus on ensuring sleep hygiene, maintaining patient orientation, and eliminating factors in the physical environment that may disrupt patient comfort. Evidence suggests strategies such as optimizing the environment, controlling light and noise, grouping patient care activities, and taking appropriate measures to preserve patients' sleep cycles to promote sleep regulation in adult ICU patients (Evidence: +1C). In the literature, studies have been conducted on the use of earplugs to protect ICU patients from noise and using eye masks to reduce exposure to light to ensure sleep hygiene. Delirium prevention strategies to be implemented should be compatible with clinical workflow. The method to be used should be easily adapted by all team members and patient relatives, and should be encouraged for use in clinical protocol. Collaboration between physicians, nurses, and patient relatives is essential in preventing delirium development. The pharmacological dimension of preventive interventions can be carried out by physicians, while non-pharmacological interventions can be implemented through collaboration between nurses and patient relatives. In this study, we aimed to determine the effect of guideline usage and team collaboration on the frequency of delirium development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The study will utilize single-blind masking

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

  • Aged 18 and above,
  • Without motor, sensory, or hearing impairment,
  • Able to communicate,
  • Admitted to the intensive care unit within the first 24 hours of admission,
  • Without chronic cerebral damage,
  • Richmond Agitation Sedation Scale value between -1 and +1 at the beginning of the study,
  • Nursing Delirium Screening Scale (Nu-DESC) score <2,
  • No wounds or infections in the ears or eyes,
  • Patients who have given consent to participate in the study.

排除标准

  • Patients who receive sedation or require sedation during the data collection process, those who are unable to communicate due to intubation, those with diagnosed psychiatric disorders, those with profound hearing loss affecting communication, and those who do not wish to use eye masks and earplugs will be excluded from the study.

结局指标

主要结局

In patients receiving Delirium Prevention Guidelines, the rate of delirium development is change compared to the control group at the end of one week.

时间窗: 3 weeks

prevent delirium

次要结局

未报告次要终点

研究者

发起方
Istanbul Demiroglu Bilim University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ogretim Uyesi Serpil Topcu

Assistant Professor

Istanbul Demiroglu Bilim University

研究点 (2)

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