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Набор скоро начнётся NCT07391631

Preoperative and Postoperative Fasting and Delirium

— Наблюдательное Postoperative Delirium Perioperative Fasting

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Postoperative Delirium Perioperative Fasting. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Relationship Between Preoperative and Postoperative Fasting Durations and Postoperative Delirium

Обзор

Postoperative delirium is a common and serious complication after surgery, especially in older patients, and is associated with prolonged hospital stay and worse recovery. Fasting before and after surgery is a routine part of perioperative care; however, prolonged fasting may negatively affect recovery and brain function. This prospective, observational, multicenter study aims to evaluate the relationship between preoperative and postoperative fasting durations and the development of postoperative delirium in adult patients undergoing elective or emergency surgery under general or regional anesthesia. Fasting times before and after surgery will be recorded. Patients will be assessed for postoperative delirium during the first three postoperative days using validated screening tools. No additional interventions will be applied, and all patients will receive standard perioperative care. The results of this study may help identify whether prolonged fasting is associated with a higher risk of postoperative delirium and may contribute to improving perioperative fasting practices and patient safety.

Подробное описание

This is a prospective, observational, multicenter study designed to investigate the association between preoperative and postoperative fasting durations and the occurrence of postoperative delirium in adult surgical patients.

Adult patients (≥18 years) undergoing elective or emergency surgery under general or regional anesthesia will be included. Patients with pre-existing delirium, advanced dementia, postoperative intensive care unit admission, or inability to complete delirium assessments will be excluded.

Preoperative fasting duration will be defined as the time from the last oral intake to the induction of anesthesia. Postoperative fasting duration will be defined as the time from the end of surgery to the first oral intake. Fasting durations will be recorded for each participant.

Postoperative delirium will be assessed using validated screening tools (Confusion Assessment Method or Nursing Delirium Screening Scale) twice daily during the first three postoperative days. Routine perioperative management will not be altered for study purposes, and no study-specific interventions will be applied.

Demographic data, comorbidities, type of surgery, and perioperative clinical parameters will be collected as part of standard care. The primary objective is to evaluate the relationship between fasting durations and postoperative delirium. Secondary analyses will explore factors associated with delirium development.

Первичные конечные точки

  • Incidence of postoperative delirium [Срок оценки: During the first 3 postoperative days]
Вторичные конечные точки (1)
  • Duration of postoperative delirium [Срок оценки: During the first 3 postoperative days]

Критерии участия

Inclusion Criteria:Adults aged 18 years or older

Patients undergoing elective or emergency surgery under general or regional anesthesia

Ability to communicate and cooperate with postoperative delirium assessments

Expected postoperative hospital stay of at least 72 hours

Provision of written informed consent

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Exclusion Criteria:Presence of preoperative delirium (positive CAM or Nu-DESC ≥2)

Advanced dementia or severe cognitive impairment

Planned postoperative intensive care unit admission

Active alcohol or benzodiazepine withdrawal

Inability to complete delirium assessments due to severe hearing, vision, or speech impairment

Lack of postoperative follow-up availability

Planned cardiac surgery

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07391631 · TARD_FASTING_POD_01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗