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临床试验/NCT07722897
NCT07722897招募中不适用

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

Akdeniz University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Change in Diastolic Blood Pressure Following Rapid Sequence Intubation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in Diastolic Blood Pressure Following Rapid Sequence Intubation

时间窗: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation

Diastolic Blood pressure (MAP) measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.

Change in Systolic Blood Pressure Following Rapid Sequence Intubation

时间窗: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation

Systolic Blood pressure measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.

Change in Heart Rate Following Rapid Sequence Intubation

时间窗: Baseline, immediately after intubation, and 5, 10, and 15 minutes after intubation

Heart Rate measured before induction, immediately after endotracheal intubation, and at 5, 10, and 15 minutes after intubation in patients with BIS-confirmed adequate depth of anesthesia.

次要结局

未报告次要终点

研究者

发起方
Akdeniz University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erkan Göksu

MD

Akdeniz University Hospital

研究点 (1)

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