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Идёт набор NCT05575661

Correlation Between Postprandial Hypotension and Post-induction Hypotension in the Elderly.

— Наблюдательное Postprandial Hypotension Post-induction Hypotension

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: Postprandial Hypotension, Post-induction Hypotension. Базовые параметры: от 65 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
Китай
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

Correlation Between Postprandial Hypotension and Perioperative Adverse Events Such as Post-induction Hypotension in the Elderly: a Prospective Observational Study.

Обзор

Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly.

Подробное описание

With the deepening of the aging population in our country, the number of elderly patients undergoing surgery is also increasing. Elderly patients are at higher risk for hemodynamic instability due to organ dysfunction, decreased physiological reserve, and the coexistence of multiple chronic diseases.Postprandial hypotension (PPH) is common but often unrecognized among the elderly.PPH is defined as a fall in systolic blood pressure of \>20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of a meal.The pathophysiology of PPH is not clear, the decreased cardiovascular autonomic function may play an important role. Post-induction hypotension (PIH) occurs after induction but before surgical incision and autonomic dysfunction is regarded as one of the major mechanisms.This study aims to prospectively explore the correlation between PPH and perioperative adverse events such as PIH in the elderly.

Первичные конечные точки

  • Post-induction hypotension [Срок оценки: Within 20 minutes after induction or before incision.]
Вторичные конечные точки (4)
  • Postoperative complications [Срок оценки: Within 30 days after surgery]
  • early intraoperative hypotension （eIOH） [Срок оценки: within the first 30 minutes after the start of surgery]
  • mortality within 30 days after surgery [Срок оценки: within 30 days after surgery]
  • 12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score) [Срок оценки: within 180 days after surgery]

Критерии участия

Критерии включения

  • Elderly patients (≥ 65 years old）;
  • Patients with American Society of Anesthesiologists(ASA) grade I-III;
  • Patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour；
  • Patients with intra-tracheal intubation following intravenous general ；anesthesia induction and maintenance；

Критерии исключения

  • Patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, Buerger's disease, and Raynaud's syndrome
  • Patients with secondary hypertension, including renal hypertension and endocrine hypertension.
  • Patients with chronic kidney disease requiring dietary restrictions or dialysis.
  • Patients with Parkinson's disease or other conditions causing tremors.
  • Patients with problems related to oral food ingestion or those requiring enteral nutrition.
  • Patients with difficulties in measuring the upper extremities or communication problems that would interfere with study procedures.
  • Patients unable to remain in a supine position for at least 2 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

Китай · 1 центр
  • Peking Union Medical College Hospital — Пекин

Публикации

  • Li T, Zang H, Che L, Cui Q, Xu L. Correlation between postprandial hypotension and post-induction hypotension in the elderly: a protocol for a prospective cohort study. BMJ Open. 2025 May 30;15(5):e095466. doi: 10.1136/bmjopen-2024-095466. PMID 40447437

Идентификаторы

NCT: NCT05575661 · I-22PJ008

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗