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Идёт набор NCT06965257

Non-invasive Blood Pressure Monitoring in Carotid Surgery

— Наблюдательное Carotid Endarterectomy 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: Continuous non-invasive blood pressure monitoring.
Кому может быть актуально
Состояния в реестре: Carotid Endarterectomy 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
Франция
Следующий шаг
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Официальное название

Continuous Non-invasive Blood Pressure Monitoring During Carotid Endarterectomy Surgery

Обзор

Carotid endarterectomy surgery carries significant neurological and cardiac risks, requiring continuous monitoring of blood pressure. In standard practice, this monitoring is carried out using an arterial catheter inserted at the start of the operation. This invasive procedure is generally not well received by the patient and is a source of potential ischaemic and infectious complications. The use of a non-invasive extracorporeal device (digital cuff) for continuous measurement of arterial pressure, based on detection of the pulse wave by plethysmography, could provide an interesting alternative. Nevertheless, the concordance of blood pressure curves measured continuously by the arterial catheter and by non-invasive pulse wave analysis remains insufficiently studied for carotid endarterectomy surgery. The aim of this study was to evaluate the concordance, using the Bland-Altman method, of mean arterial pressure curves measured continuously by the invasive arterial catheter (standard management) and by non-invasive pulse wave contour analysis (non-invasive extracorporeal sensor) in carotid endarterectomy surgery. This was a non-interventional study. Patient management is carried out according to current recommendations for carotid endarterectomy surgery: placement of an arterial catheter at the start of the procedure and frontal NIRS electrodes. A non-invasive monitoring device (ClearSight™ digital cuff available on the investigation site) will then be added to measure blood pressure on the side ipsilateral to the arterial catheter.

Вмешательства

  • Другое Continuous non-invasive blood pressure monitoring
    Addition prior to anaesthetic induction of the non-invasive monitoring device (digital sleeve available at the investigation site) for blood pressure measurement on the side ipsilateral to the arterial catheter

Первичные конечные точки

  • Bland-Altman concordance analysis (accuracy, reproducibility and limits of agreement) between mean arterial pressures measured invasively (arterial catheter) and non-invasively (extracorporeal sensor) [Срок оценки: through operative care procedure, [beginning of procedure ; end of procedure]]
Вторичные конечные точки (6)
  • Bland-Altman concordance analyses (accuracy, reproducibility and limits of agreement) between systolic and diastolic arterial pressures measured invasively (arterial catheter) and non-invasively (extracorporeal sensor) [Срок оценки: through operative care procedure, [beginning of procedure ; end of procedure]]
  • Focus on the successive phases of the procedure: anaesthetic induction, before, during and after carotid clamping [Срок оценки: through operative care procedure, [beginning of procedure ; end of procedure]]
  • Invasive arterial pressure (measured in mmHg) [Срок оценки: through operative care procedure, [beginning of procedure ; end of procedure]]
  • Non-invasive arterial pressure (measured in mmHg) [Срок оценки: through operative care procedure, [beginning of procedure ; end of procedure]]
  • NIRS (measured in %) [Срок оценки: through operative care procedure, [beginning of procedure ; end of procedure]]
  • Search for measurement bias according to operators using regression models [Срок оценки: through operative care procedure, [beginning of procedure ; end of procedure]]

Критерии участия

Критерии включения

  • Patients over 18 years of age
  • Patients undergoing carotid endarterectomy surgery under general anesthetic
  • Patient who has been informed and has not objected

Критерии исключения

  • Technical or physical impossibility of inserting an arterial catheter or extracorporeal sensor (digital cuff)
  • Patient of legal age unable to express his/her opposition
  • Patient under guardianship, curatorship or legal protection
  • Patient deprived of liberty

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Assistance Publique Hôpitaux de Paris - CHU Henri Mondor - DMU CARE — Créteil

Идентификаторы

NCT: NCT06965257 · APHP250362 · 2025-A00444-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗