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Набор скоро начнётся NCT07316634

Correlation Between Postoperative Blood Pressure Variability, Perfusion Index and Perioperative Adverse Events in Cardiac Surgery

— Наблюдательное Cardiac Surgery Intensive Care Treatment Hemodynamics

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: Blood Pressure Variability and Perfusion Index.
Кому может быть актуально
Состояния в реестре: Cardiac Surgery Intensive Care Treatment, Hemodynamics. 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

Correlation Between Postoperative Blood Pressure Variability, Perfusion Index and Perioperative Adverse Events in Cardiac Surgery: A Single-Center Prospective Observational Cohort Study

Обзор

In patients after cardiac surgery, disturbances in macrocirculatory fluctuations and tissue perfusion commonly coexist. The stress state induced by factors such as surgical manipulation, cardiopulmonary bypass, anesthetic agents, pain, and ischemia-reperfusion injury, along with the use of vasoactive drugs postoperatively, often leads to increased blood pressure fluctuations in the early postoperative period. Additionally, dysregulation of organ blood flow autoregulation post-surgery contributes to peripheral circulatory impairment, rendering perfusion pressure an unreliable indicator of actual organ perfusion. We aim to assess postoperative blood pressure fluctuation using blood pressure variability and evaluate peripheral circulatory status via the perfusion index. In this prospective cohort study, we will examine the correlation between these two parameters and perioperative adverse events.

Вмешательства

  • Другое Blood Pressure Variability and Perfusion Index
    All patients in this cohort will undergo invasive hemodynamic monitoring and noninvasive pulse oximetry, postoperative 24-hour blood pressure variability (from minute-to-minute invasive arterial pressure data) and perfusion index (from half-hourly recordings) were obtained through these monitoring modalities.

Первичные конечные точки

  • Incidence of the composite endpoint of adverse events within 30 days postoperatively [Срок оценки: Within 30 days after surgery]
Вторичные конечные точки (6)
  • Incidence of low cardiac output syndrome within 30 days postoperatively. [Срок оценки: Within 30 days after surgery]
  • Incidence of acute kidney injury within 30 days postoperatively. [Срок оценки: Within 30 days after surgery]
  • Incidence of acute respiratory distress syndrome within 30 days postoperatively [Срок оценки: Within 30 days after surgery]
  • Incidence of new-onset atrial arrhythmias within 30 days postoperatively. [Срок оценки: Within 30 days after surgery]
  • Incidence of prolonged ventilation (>24 hours) within 30 days postoperatively. [Срок оценки: Within 30 days after surgery]
  • Length of intensive care unit stay [Срок оценки: Within 30 days after surgery]

Критерии участия

Критерии включения

  • Age at surgery ≥ 18 years
  • Patients admitted to the ICU for the first time after undergoing their first cardiac surgical procedure during the current hospitalization ③ Expected to receive continuous invasive blood pressure monitoring and noninvasive pulse oximetry monitoring for at least 12 hours postoperatively in the ICU ④ Written or verbal informed consent obtained from the patient or their family members

Критерии исключения

  • Patients with severe peripheral vascular disease in the arm used for noninvasive pulse oximetry monitoring
  • Patients not undergoing invasive hemodynamic monitoring ③ Patients requiring preoperative or intraoperative support with IABP or ECMO
  • Patients expected to have incomplete postoperative monitoring data or a monitoring duration of less than 12 hours
  • Postoperative patients who are not admitted to the ICU for the first time during the current hospitalization ⑥ Patients admitted to the ICU prior to undergoing cardiac surgery ⑦ Patients with critically insufficient baseline preoperative data

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: NCT07316634 · KS2025145

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗