Awake Intubation in Difficult Airway- a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Intubation success
研究概览
简要总结
Nowadays, the gold standard for difficult airway management is awake intubation with a flexible fiberscope. Alternatively, when the flexible fiberscope is unable to facilitate tracheal intubation, rigid stylets may be used. One newly developed rigid video stylet also features a flexible tip (C-MAC VS, Karl Storz AG, 78532 Tuttlingen, Germany). The distal angular offset of the C-MAC VS, in which the camera and light sources are integrated, can be aligned (up to 60°) to the patient's anatomical structures to facilitate intubation.
Although awake intubation is less comfortable for the patient and more time consuming, there are several reasons why this is often performed. The investigators plan a prospective observational with 36 participants using the C-MAC VS on adult patients with indication for awake oral intubation.
To ease the placement of the tube (intubation), the investigators will use local anesthesia of the mucosa in the mouth, pharynx and larynx.
The main purpose of the study is to prove the feasibility of successful awake intubation with the C-MAC VS in adult patients. If the new device proves reliable in facilitating awake oral, future patients benefit from an additional tool that allows fast and safe intubation in difficult airway situations.
详细描述
In the majority of cases, airway management is uncomplicated and a straightforward procedure. Nevertheless, in rare cases complications are associated with notably high rates of serious consequences.
Therefore, assured and reliable intubation is fundamental to safe anesthetic practice.
Various approaches were introduced by the medical device industry to optimize intubation procedure. Nowadays, the gold standard for difficult airway management is awake intubation with a flexible fiberscope. Alternatively, when the flexible fiberscope is unable to facilitate tracheal intubation, rigid stylets may be used. One newly developed rigid video stylet also features a flexible tip (C-MAC VS, Karl Storz AG, 78532 Tuttlingen, Germany). The C-MAC VS is an advancement of the rigid "Bonfils" stylet (Karl Storz, Karl Storz AG, 78532 Tuttlingen, Germany). The distal angular offset of the C-MAC VS, in which the camera and light source are integrated, can be aligned (up to 60°) to the patient's anatomical structures to facilitate intubation.
Although awake intubation is less comfortable for the patient and more time consuming, there are several reasons why this is often performed.
In this research project, the investigators plan a prospective observational study using the C-MAC VS on adult patients with indication for awake oral intubation. Spontaneous ventilation will be maintained until confirmation of tracheal intubation.To ease the placement of the tube (intubation), the investigators will use local anesthesia of the mucosa in the mouth, pharynx and larynx.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for awake oral intubation
- •elective surgery
- •age 18-80
- •written Informed Consent
- •knowledge of the German language enough to understand the Informed Consent
排除标准
- •emergency patients
- •uncooperative patients
- •ASA (= Physical Status Classification System) V
- •study equipment and personal not available
结局指标
主要结局
Intubation success
时间窗: 120 seconds
The intubation success rate at first attempt in less than 120 seconds
次要结局
- Patient's comfort during intubation(On the 1st post-procedure day)
- Patients demographic data such as size(During the process of screening, up to 24 hours before the study session starts)
- Airway- and intubation data(Device passes patients lips until the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown (the entire process should not pass 120 seconds))
- Duration of the airway management(Device passes patients lips until the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown (the entire process should not pass 120 seconds))
- Total number of intubation attempts(The first time the device passes patients lips until the respiratory is secured so the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown.)
- Patients demographic data such as weight(During the process of screening, up to 24 hours before the study session starts)
- Patients demographic data such as gender(During the process of screening, up to 24 hours before the study session starts)
- Patients demographic data such as BMI(During the process of screening, up to 24 hours before the study session starts)
- Patients vital parameter such as blood pressure(Device passes patients lips until the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown (the entire process should not pass 120 seconds))
- Patients vital parameter such as heart rate(Device passes patients lips until the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown (the entire process should not pass 120 seconds))
- Patients vital parameter such as the arterial oxygen saturation(Device passes patients lips until the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown (the entire process should not pass 120 seconds))
- The anesthetist rates the patients airway(Device passes patients lips until the device is completely removed out of the tracheal tube and the first end tidal CO2 is shown (the entire process should not pass 120 seconds))