Идёт набор NCT05847010

Accompanying Scientific Program for the Quality Contract Prevention of Postoperative Delirium in the Care of Older Patients (WB-QC-POD)

— Наблюдательное Postoperative Delirium

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. Базовые параметры: от 70 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: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

In the course of a scientific accompanying program, the project pursues the goal of gaining further insight into a possible connection between various influencing factors and the development of postoperative delirium. Against this background, in addition to the primary goal of exploring delirium rates, we aim to identify associations between other secondary end goals like the internal circadian time or the heart rate variability and the occurrence of postoperative delirium. For this purpose, patients of the QC-POD (NCT04355195) sample will be studied.

Подробное описание

The project aims to improve the understanding of the internal circadian time (chronotype) and other sleep parameters, as well as further secondary end goals, in relation to the development of postoperative delirium. In the course of this the project would like to investigate the perioperative heart rate variability. Also, the association of perioperative peripheral cholinesterase activity with perioperative heart rate variability and the development of POD will be explored. Additionally, the investigator will analyze the correlation of intraoperative EEG signatures with perioperative heart rate variability, and explore any association of core body temperature and the development of postoperative Delirium.

Первичные конечные точки

Incidence of postoperative Delirium [Срок оценки: Up to the fifth postoperative day]

Вторичные конечные точки (12)

Duration of Delirium [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days]
Bodytime [Срок оценки: Before surgery]
Chronotype 1 [Срок оценки: Up to three months]
Chronotype 2 [Срок оценки: Up to three months]
Heart rate variability 1 [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days.]
Heart rate variability 2 [Срок оценки: The participants are followed up until the end of hospital stay, an expected average of 7 days.]
Body core temperature [Срок оценки: Up to the third postoperative day]
Electroencephalography signatures [Срок оценки: During surgery, an expected time of two hours.]
Sleep monitoring 1 [Срок оценки: Up to the third postoperative day]
Sleep monitoring 2 [Срок оценки: Up to the third postoperative day]
Sleep monitoring 3 [Срок оценки: Up to the third postoperative day]
Insomnia Severity Index [Срок оценки: Up to three months]

Критерии участия

Критерии включения

Age ≥ 70 years
Male and female patients
Patients who have been included in QC-POD
Eligible patients\* for inclusion: informed consent by the patient, preoperatively with verbal and written informed consent before the start of data collection
Incapacitated patients for inclusion: Written informed consent by a legal representative
surgery (elective and not elective)