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Набор скоро начнётся NCT06685263

Development of Perioperative Delirium Prediction Model

— Наблюдательное Cardiovascular Surgery

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
В протоколе указаны: Group 1, Group 2.
Кому может быть актуально
Состояния в реестре: Cardiovascular Surgery. 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

Development of a Perioperative Delirium Prediction Model in Patients Undergoing Cardiovascular Surgery

Обзор

Postoperative delirium is an acute organic brain dysfunction that is commonly observed following cardiovascular surgery. It presents with acute and fluctuating changes in the level of consciousness, resulting in impaired cognitive function and perception. The incidence of delirium following cardiac surgery has been reported to range from 11.4% to 55%. In light of the challenges associated with treating delirium once it has manifested, it is imperative to prioritise the early recognition and prevention of this condition. The objective of this study was to develop a perioperative delirium risk prediction model for patients undergoing cardiovascular surgery.

Подробное описание

Postoperative delirium is associated with an increased incidence of postoperative complications, which in turn lead to cognitive dysfunction, increased mortality, and the need for long-term care. It is predicted in the literature that the early detection of delirium cases, of which 30% are known to be preventable, improves prognosis. Accordingly, a prediction model based on the identification of delirium risk factors can categorise intensive care patients into distinct risk levels according to their probability of developing delirium, thus enabling healthcare professionals to ascertain the likelihood of delirium and implement suitable preventive measures. A review of the literature reveals the existence of numerous delirium prediction models designed to identify patients at high risk of developing delirium. However, there is a paucity of studies examining models for predicting delirium risk in the context of cardiovascular surgery. The objective of this study is to develop a delirium risk prediction model for the perioperative period in patients undergoing cardiovascular surgery.

Вмешательства

  • Поведенческое Group 1
    The development group comprises 385 individuals. Following the data collection phase of the development group, the independent risk factors for the onset of delirium will be identified through statistical analysis. A delirium prediction model will then be constructed using the identified risk factors.
  • Поведенческое Group 2
    The validation group comprises 385 individuals. The delirium prediction model created using the data from the development group will be validated by testing the data from the validation group. This will enable the evaluation of the model's fit and calibration in predicting delirium.

Первичные конечные точки

  • Development of a delirium risk prediction model [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Over 18 years old
  • Previous cardiovascular surgery
  • No mental deficiency and visual and hearing impairment
  • Participants' acceptance to participate in the research
  • The patient is not in coma (RASS score between -3 and +4, GCS score of 10 and above)

Критерии исключения

  • Cardiovascular surgery under emergency conditions
  • Being diagnosed with delirium, dementia, psychiatric illness and taking medication for this reason before the surgery
  • Serious conditions such as cardiopulmonary resuscitation during surgery
  • Alcohol and drug addiction
  • Duration of mechanical ventilation exceeding 36 hours
  • Dying in the intensive care unit within 24 hours

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.

Публикации

  • Rudolph JL, Jones RN, Levkoff SE, Rockett C, Inouye SK, Sellke FW, Khuri SF, Lipsitz LA, Ramlawi B, Levitsky S, Marcantonio ER. Derivation and validation of a preoperative prediction rule for delirium after cardiac surgery. Circulation. 2009 Jan 20;119(2):229-36. doi: 10.1161/CIRCULATIONAHA.108.795260. Epub 2008 Dec 31. PMID 19118253
  • Xu Y, Meng Y, Qian X, Wu H, Liu Y, Ji P, Chen H. Prediction model for delirium in patients with cardiovascular surgery: development and validation. J Cardiothorac Surg. 2022 Oct 1;17(1):247. doi: 10.1186/s13019-022-02005-3. PMID 36183105

Идентификаторы

NCT: NCT06685263 · 2024-15/3

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗