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Идёт набор NCT07722897

Assessment of Hemodynamic Responses at Adequate Depth of Anesthesia Using Bispectral Index During Rapid Sequence Intubation in the Emergency Department

— Наблюдательное Critical Illness

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: Bispectral Index (BIS) Monitoring.
Кому может быть актуально
Состояния в реестре: Critical Illness. 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
Turkey (Türkiye)
Следующий шаг
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Обзор

Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease. Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult. The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.

Подробное описание

Rapid sequence intubation (RSI) is the standard approach for emergency airway management in critically ill patients requiring endotracheal intubation. Laryngoscopy and tracheal intubation may provoke significant hemodynamic responses, including increases in heart rate and blood pressure, which may adversely affect patients with severe neurological or cardiovascular disease.

Although hemodynamic responses during tracheal intubation have been extensively investigated in the anesthesiology literature, evidence from emergency department settings remains limited. Furthermore, previous studies have rarely confirmed whether an adequate depth of anesthesia had been achieved before laryngoscopy, making interpretation of hemodynamic responses difficult.

The aim of this prospective observational study is to evaluate hemodynamic responses during rapid sequence intubation in adult emergency department patients after confirming adequate depth of anesthesia using bispectral index (BIS) monitoring. Heart rate and blood pressure will be recorded before induction, during intubation, and after successful endotracheal intubation, allowing objective assessment of the hemodynamic response under confirmed adequate anesthetic depth.

Вмешательства

  • Устройство Bispectral Index (BIS) Monitoring
    Bispectral index monitoring is used to assess the depth of anesthesia before laryngoscopy. Endotracheal intubation is performed after an adequate BIS value has been achieved.

Первичные конечные точки

  • Change in Diastolic Blood Pressure Following Rapid Sequence Intubation [Срок оценки: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation]
  • Change in Systolic Blood Pressure Following Rapid Sequence Intubation [Срок оценки: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation]
  • Change in Heart Rate Following Rapid Sequence Intubation [Срок оценки: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation]

Критерии участия

Критерии включения

Adults aged 18 years or older. Patients undergoing rapid sequence intubation (RSI) in the emergency department.

Patients in whom bispectral index (BIS) monitoring can be applied before laryngoscopy.

Patients achieving an adequate depth of anesthesia (BIS 45-55) before laryngoscopy.

Written informed consent obtained from the patient or a legally authorized representative, when applicable according to local ethics requirements.

Критерии исключения

Age <18 years. Cardiac arrest before or during induction. Patients requiring immediate ("crash") intubation without sufficient time for BIS monitoring.

Inability to obtain reliable BIS monitoring (e.g., technical failure or inability to place the sensor).

Pregnancy. Facial or scalp conditions preventing BIS sensor placement. Prisoners or other vulnerable populations if excluded by the ethics protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Akdeniz University Hospital — Antalya

Публикации

  • Forbes AM, Dally FG. Acute hypertension during induction of anaesthesia and endotracheal intubation in normotensive man. Br J Anaesth. 1970 Jul;42(7):618-24. doi: 10.1093/bja/42.7.618. No abstract available. PMID 5453244

Идентификаторы

NCT: NCT07722897 · AkdenizUH1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗