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集中治療患者のためのせん妄予防ガイドライン

2026年11月4日 更新者:Ogretim Uyesi Serpil Topcu、Istanbul Demiroglu Bilim University

集中治療患者に対するせん妄予防ガイドライン活用の有効性評価

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

160

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的:Experimental

In the intervention group, initially, the Patient Identification Form, RASS, and Nu-DESC will be administered. The RASS and Nu-DESC forms will continue to be applied once a day throughout the patient's follow-up period in the intensive care unit, every 12 hours. Each intervention group patient randomized will receive the Delirium Prevention Guideline. The guideline includes standard practices used by intensive care nurses in patient monitoring. In addition to routine follow-ups, eye masks and earplugs will be applied to patients in the intervention group between 24:00 and 06:00. It is expected that the guideline will be used once every 24 hours, in the morning, to ensure standardization

Each intervention group patient randomized will receive the Delirium Prevention Guideline. The guideline is designed to be followed by nurses. However, collaboration with the physician is required for some aspects of the guideline (pain control, ordering/follow-up of laboratory tests, etc.). Support will be obtained from the intensive care physician, who is a member of the research team, for these steps. The guideline includes standard practices used by intensive care nurses in patient monitoring. In addition to routine follow-ups, eye masks and earplugs will be applied to patients in the intervention group between 24:00 and 06:00.

介入なし:Control

Routine delirium monitoring conducted in the intensive care clinic will be performed for patients in this group. There is no standard form used for delirium in the unit where the study is conducted. At the beginning of data collection, the Control group patients will undergo the Patient Identification Form, RASS, and Nu-DESC (once every 12 hours). The RASS and Nu-DESC forms will continue to be applied once a day throughout the patient's follow-up period in the intensive care unit. Data collection will be terminated in case of delirium development in patients.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
In patients receiving Delirium Prevention Guidelines, the rate of delirium development is change compared to the control group at the end of one week.
時間枠:3 weeks

prevent delirium

3 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年6月15日

一次修了 (実際)

2025年2月15日

研究の完了 (実際)

2025年3月15日

試験登録日

最初に提出

2024年4月26日

QC基準を満たした最初の提出物

2024年5月3日

最初の投稿 (実際)

2024年5月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2025年4月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Researchers may share IPD data after the completion and publication of the study.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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