跳至主要内容
临床试验/NCT07690254
NCT07690254招募中不适用

Evaluation of First-Pass Endotracheal Intubation Success Using the Bispectral Index in Patients Undergoing Endotracheal Intubation in the Emergency Department

Akdeniz University Hospital1 个研究点 分布在 1 个国家目标入组 150 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
150
试验地点
1
主要终点
First-pass endotracheal intubation success

研究概览

简要总结

This prospective observational study aims to evaluate the association between anesthetic depth, measured by the Bispectral Index (BIS), and first-pass endotracheal intubation success in adult patients undergoing rapid sequence intubation (RSI) in the emergency department.

Endotracheal intubation is one of the most critical procedures performed in emergency medicine. Multiple intubation attempts are associated with an increased risk of adverse events, including hypoxemia, aspiration, cardiovascular complications, and death. Although several factors influence first-pass intubation success, the contribution of anesthetic depth at the time of intubation has not been adequately investigated in the emergency department.

Patients for whom the treating emergency physician decides to perform RSI will undergo noninvasive BIS monitoring using a disposable forehead sensor. The physician performing the intubation will remain blinded to the BIS value throughout the procedure and will perform intubation according to routine clinical practice. A separate investigator, who is not involved in patient management, will record the BIS value at the time of intubation.

The BIS measurements will not be disclosed to the treating team and will not influence clinical decision-making, medication dosing, or patient management. The study is purely observational and does not evaluate the performance or effectiveness of the BIS device itself.

The primary objective is to determine whether patients who achieve first-pass intubation success differ in anesthetic depth from those requiring multiple intubation attempts.

详细描述

Endotracheal intubation is a life-saving intervention frequently performed in the emergency department for patients with airway compromise, respiratory failure, or critical illness. Despite its importance, emergency airway management is associated with a substantial risk of adverse events. Previous studies have consistently demonstrated that multiple intubation attempts significantly increase the likelihood of hypoxemia, aspiration, hypotension, cardiac arrest, airway trauma, and mortality. Therefore, achieving first-pass success has become one of the principal quality indicators in emergency airway management.

Several patient-, operator-, and procedure-related factors influence first-pass success, including anatomical difficulty, operator experience, type of laryngoscope, choice of sedative and neuromuscular blocking agents, and optimization of preoxygenation. Another potentially important but understudied factor is the depth of anesthesia at the moment of laryngoscopy and intubation.

Adequate anesthetic depth before laryngoscopy suppresses airway reflexes, minimizes patient movement, and improves intubating conditions. Previous studies comparing succinylcholine and rocuronium have suggested differences in intubation conditions; however, subsequent investigations demonstrated that these differences were largely attributable to dosing strategies rather than the neuromuscular blocking agent itself. Current evidence indicates that when appropriate doses are administered, both agents provide comparable intubating conditions. Nevertheless, regardless of the neuromuscular blocking agent used, insufficient hypnotic depth may adversely affect intubation conditions.

The Bispectral Index (BIS) is a processed electroencephalographic parameter ranging from 0 to 100 that provides an objective assessment of the patient's level of consciousness. BIS monitoring has been extensively validated in the operating room and has demonstrated a strong correlation with anesthetic depth. Randomized clinical trials have shown that BIS-guided anesthesia reduces the incidence of intraoperative awareness and may facilitate individualized anesthetic administration. However, BIS monitoring is not routinely incorporated into emergency airway management, and limited evidence exists regarding its relationship with first-pass intubation success in emergency department patients.

This study is designed as a prospective observational study. Adult patients undergoing rapid sequence intubation after a clinical decision by the treating emergency physician will be consecutively enrolled. A disposable BIS sensor will be placed on the patient's forehead immediately before induction, and BIS monitoring will be performed continuously. The emergency physician performing the intubation will remain blinded to the BIS values throughout the procedure. A separate investigator, independent of clinical management, will record the BIS value at the time of laryngoscopy and intubation.

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
  • No traumatic injury to the frontal region that would interfere with placement of the Bispectral Index (BIS) sensor

排除标准

  • Age younger than 18 years
  • Pregnant patients
  • Patients with cardiac arrest or hemodynamic instability at the time of enrollment
  • Patients intubated without the rapid sequence intubation (RSI) protocol
  • Refusal to participate in the study (by the patient or, where applicable, a legally authorized representative)

结局指标

主要结局

First-pass endotracheal intubation success

时间窗: During the intubation procedure

Intubation at first attempt

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)

Loading locations...

相似试验