Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)
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: FOCUS echocardiography.
- Кому может быть актуально
- Состояния в реестре: Echocardiography, Hip Fractures, Risk Assessment, Anesthesia. 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
- 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
Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery - Study Protocol for a Randomized Controlled Trial
Обзор
The primary objective of this study is to investigate the impact of preoperative focused transthoracic ultrasound (FOCUS) on intraoperative hypotension and postoperative complications in hip fracture surgery. Our hypothesis is that a preoperative FOCUS along with a hemodynamic optimization protocol will reduce the occurrence of intraoperative drops in blood pressure and post-operative complications.
Подробное описание
Hip fracture surgery is a common procedure, and despite progress in perioperative management, cardiac complications are common, and the post-operative mortality remains high. In this geriatric patient population, cardiac disease as well as varying degrees of dehydration is common, and preoperative knowledge of these conditions have a key role in enabling a proactive perioperative hemodynamic management. However, clinical assessment is surprisingly unreliable and has been shown to easily fail to identify significant cardiac disease and lack of venous return.
Transthoracic echocardiography (TTE) is a well-established and non-invasive investigation that can identify cardiac disease and aberrations in volume status prior to surgery. In a preoperative practice, the use of focused cardiac ultrasound (FOCUS) enables an individualized anesthesia management and has been demonstrated to influence anesthesiologist decision making. Furthermore, measurements of inferior vena cava used as a surrogate for venous return have been shown to be a predictor of intraoperative hypotension.
Patients scheduled for daytime hip fracture surgery will be screened for eligibility.
Random allocation (1:1 allocation ratio) of patients to receive standard care (control group) or standard care + preoperative focused cardiac ultrasound with a preoperative hemodynamic optimization (intervention group). Registration of pre- and intraoperative blood pressure, as well as post-operative complications and mortality will be conducted.
Primary outcome measure: Intraoperative hemodynamic instability defined as MAP \< 60 mmHg.Secondary outcome measures: Time to surgery, length of hospital stay, renal failure, cardiac complications (myocardial ischemia, heart failure, post-operative atrial fibrillation, pulmonary edema, pulmonary embolism), 7-,30- and 90-day mortality.
Вмешательства
- Диагностический тест FOCUS echocardiography
Preoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs
Первичные конечные точки
- Blood pressure drop [Срок оценки: From date of randomization up to 4 hours]
Вторичные конечные точки (6)
- Change of blood pressure level [Срок оценки: From date of randomization up to 4 hours]
- Lowest level of blood pressure (MAP) [Срок оценки: From date of randomization up to 4 hours]
- Acute kidney failure [Срок оценки: From date of randomization up to 48 hours]
- Myocardial injury [Срок оценки: From date of randomization up to 48 hours]
- Readmission [Срок оценки: From date of randomization up to 7 days]
- Mortality [Срок оценки: From date of randomization up to 90 days]
Критерии участия
Критерии включения
- Patients ≥ 65 years of age, with American Socieity of Anesthesiologists (ASA) physical status classification 2-4, that are scheduled for acute hip fracture surgery (ICD-codes s72.0, s72.00, s72.01, s72.1, s72.2)
Критерии исключения
- Metastatic cancer and/or suspect pathological fracture.
- Concurrent other fracture/surgery.
- Reoperation within 72 hours from primary operation.
- Severe dementia.
- Preoperative echocardiography for other reason than participation in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT05862493 · Dnr 2022-05628-01