Ultrasound-Guided Bougie Insertion Technique and Conventional Method in Difficult Intubation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Duration of bougie insertion.
研究概览
简要总结
Difficult airway management remains one of the biggest challenges in anesthesia practice. The Gum elastic bougie, an intubation tool, is frequently used to facilitate intubation in difficult situations. Recently, ultrasound-guided airway management has been used as a potential method to improve the intubation process. This study aims to compare the efficacy of ultrasound-guided bougie insertion with the conventional method regarding the duration of endotracheal tube (ETT) insertion and the number of attempts required in a difficult intubation population.
The goal of this clinical trial is to learn if using ultrasound during bougie insertion in difficult airway patients will improve the success rate and reduce the time of insertion. The main questions it aims to answer are:
Does using ultrasound reduce the number of insertion attempts? Does using ultrasound reduce the duration of bougie insertion?
Researchers will compare the ultrasound-guided technique to the conventional bougie insertion method. They will also assess both groups' hemodynamic parameters during and after the procedure and the success rate from the first trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 15 -75 years.
- •Elective surgical operation.
- •ASA (American Society of Anesthesiologists) physical status I-III.
- •Predicted difficult airway.
排除标准
- •Emergency intubations.
- •Patients with contraindications to the use of bougie.
- •Patients with a known allergy to local anesthetics or ultrasound gel.
- •Pregnancy.
- •Craniofacial anomaly
- •Patients with obstructive sleep apnea
- •Patient with gastroesophageal reflux disease.
研究组 & 干预措施
Group A: Ultrasound-guided bougie insertion
the ultrasound will be used to provide a real-life observation of the bougie advancement into the trachea to confirm its correct placement.
干预措施: ultrasound guided bougie insertion (Procedure)
Group B: Conventional bougie insertion
using the conventional method for bougie insertion
干预措施: Conventional methods for bougie insertion (Procedure)
结局指标
主要结局
Duration of bougie insertion.
时间窗: during the insertion of bougie
the time in seconds from the start of the bougie insertion to successful ETT placement
Number of attempts required for successful bougie insertion
时间窗: during the insertion of bougie
As each separate insertion of the bougie: if the bougie cannot visualized by the ultrasound in (group A) OR if the depth of the bougie reaches 30 centimeters depth from the angle of the mouth without feeling the resistance in (group B), the bougie will be withdrawn and reinserted again.
次要结局
- Systolic and daistolic blood pressure changes during intubation(T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation)
- Success rate of the first attempt(during the insertion of bougie)
- Hemodynamic changes during intubation(T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation)
- Heart rate during the procedure(Pulse rate per minute T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation)
研究者
Mohammed Gaber Saad
Lcturer of anesthesia, intensive care and pain medicine
Al-Azhar University