Ultrasound of the Anterior Neck Tissues, as a New Tool in the Evaluation of Difficult Airway.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Incidence of difficult intubation
研究概览
简要总结
Current guidelines support the use of predictive clinical tests in the evaluation of difficult airway, meaning either difficult bag and mask ventilation, conventional laryngoscopy and/or endotracheal intubation. However, despite the clinical use of these predictive tests, unpredictive difficult laryngoscopy complicates 1.5-13% of cases. Life threatening scenarios may be encountered in patients with difficult or impossible bag and mask ventilation.
Anaesthesiologists are familiar with the use of ultrasound, with peripheral nerve blockade and central vascular access representing the most popular applications during the last decades. The ultrasound provides real time and accurate images. According to the current literature, there are only a handful of studies relevant to the application of point of care ultrasound (POCUS), as a new tool in the upper airway evaluation. It is a new field of research with high interest.
This is a prospective observational study to investigate if specific ultrasound measurements of the anterior neck can serve as predictors of difficult airway. The ultrasound parameters will be measured preoperatively, during the preanaesthetic evaluation, along with standard clinical prognostic tools, like the mallampati score. The ultrasound parameters to be investigated are:
- the distance from thyroid isthmus to skin surface,
- the distance from the hyoid bone to the skin surface,
- the distance from the anterior commissure of vocal cords to the skin surface,
- the distance from skin to the trachea at the level of jugular notch,
- the distance from skin to epiglottis corresponding to half of the distance between thyroid cartilage and hyoid bone,
- and the angle between glottis and epiglottis. After the induction in anaesthesia, the Cormack Lehane score (grading of the laryngoscopy view) and the Han scale (grading of the degree of difficulty of bag and mask ventilation) will also be recorded.
The goal of this study is the investigation of the role of POCUS in the evaluation of difficult bag and mask ventilation and difficult intubation. The primary endpoint is the incidence of difficult bag and mask ventilation and the incidence of difficult laryngoscopy and intubation. Secondary endpoints are the correlations between clinical prognostic tools of difficult airway and the POCUS parameters under investigation.
详细描述
Ultrasound of the anterior neck tissues, as a new tool in the evaluation of difficult airway.
Introduction The current guidelines provide predictive clinical tests in the evaluation of difficult airway, relevant to the mask ventilation, conventional laryngoscopy and endotracheal intubation. Despite similarities in predictors, the incidence of mask ventilation is distinct from difficult laryngoscopy and intubation, 7.8% and 12.3% respectively.
However, despite the clinical use of these predictive tests, unpredictive difficult laryngoscopy complicates 1.5-13% of cases. The risk of life-threatening complications is increased in patients with difficult or impossible bag and mask ventilation.
Anaesthesiologists are familiar with the use of ultrasound, with peripheral nerve blockade and central vascular access representing the most popular applications of the last decades. Ultrasound provides quick, easy and accurate images.
According to the current literature, there are a few studies relevant to the application of point of care ultrasound (POCUS), as a new tool in the upper airway evaluation. It is a new field of research with high interest.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age>18, elective surgery under general anesthesia with endotracheal intubation
排除标准
- •obstetric surgeries,
- •pregnancy,
- •non elective surgeries,
- •patients with previous surgeries involving the anterior surface of the neck (i.e., thyroid surgery),
- •patients with history of cervical radiation.
结局指标
主要结局
Incidence of difficult intubation
时间窗: From the beginning of the pre-oxygenation period up to securing the airway, with either up to 3 attempts of conventional laryngoscopy/intubation, or non-conventional intubation, or waking up the patient, whichever comes first.
Difficult intubation is defined as requirement of more than three attempts with conventional laryngoscopy.
Incidence of difficult bag and mask ventilation
时间窗: From the beginning of the pre-oxygenation period up to securing the airway, with either up to 3 attempts of conventional laryngoscopy/intubation, or non-conventional intubation, or waking up the patient, whichever comes first.
Difficult mask ventilation is defined as the inability of an unassisted anesthesiologist to maintain the measured oxygen saturation as measured by pulse oximetry \> 92% or to prevent or reverse signs of inadequate ventilation during positive-pressure mask ventilation under general anesthesia.
次要结局
- Distance from thyroid isthmus to skin surface(24 hours before elective surgery and general anaesthesia needing endotracheal intubation, during the pre-anesthetic visit.)
- Distance from hyoid bone to skin surface(24 hours before elective surgery and general anaesthesia needing endotracheal intubation, during the pre-anesthetic visit.)
- Cormack-Lehane classification(From the beginning of the pre-oxygenation period up to the first, second or third attempt of conventional laryngoscopy, whichever comes first.)
- Han scale classification(From the beginning of the pre-oxygenation period up to securing the airway, with either up to 3 attempts of conventional laryngoscopy/intubation, or non-conventional intubation, or waking up the patient, whichever comes first.)
- Distance from anterior commissure to skin surface(24 hours before elective surgery and general anaesthesia needing endotracheal intubation, during the pre-anesthetic visit.)
- Distance from trachea to skin surface(24 hours before elective surgery and general anaesthesia needing endotracheal intubation, during the pre-anesthetic visit.)
- Distance from epiglottis to skin surface(24 hours before elective surgery and general anaesthesia needing endotracheal intubation, during the pre-anesthetic visit.)
- Angle between the epiglottis and glottis(24 hours before elective surgery and general anaesthesia needing endotracheal intubation, during the pre-anesthetic visit.)
研究者
Agathi Karakosta
Assistant Professor of Anaesthesiology
University of Ioannina