Ultrasound is Superior to Conventional Palpation Method in Identification of the Cricothyroid Membrane in Subjects With Poorly Defined Neck Landmarks: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 4
- 主要终点
- accuracy in identification of the Cricothyroid Membrane
研究概览
简要总结
Routine surgery requires artificial breathing through the placement of a plastic tube into the patient's windpipe via mouth or nose. This tube serves as the source of providing oxygen to the patients during surgery. Difficulties during insertion of this tube may lead to serious complications and during this life-threatening crisis the only way to provide oxygen to the patient is by the help of a procedure called cricothyrotomy (CTY).
CTY is a life saving procedure that involves an incision on the patient neck at a very precise location called Cricothyroid Membrane (CTM). The current method of identifying this location is by palpation of neck cartilages by the operator. The incorrect identification of the CTM could lead to many complications. In certain patients such as obese or distorted neck features the identification of CTM would be difficult. Ultrasound (US) has improved the success rate of many anesthesia procedures .Its use has been described for identification of neck structures; however, this technique of localization has not been validated against the gold standard which is the use of CT scan. The purpose of our study is to determine the precision of identifying the CTM using the US versus the conventional finger palpation when compared to the gold standard.
详细描述
Inability to secure the airway remains the most frequent cause of anesthesia-related mishaps.Difficult airway management continues to be the major challenge in anesthesia as it is responsible for a third of anesthesia-related claims and is the single largest class of closed claim injury suits. Difficulties in tracheal intubation is the most frequent cause of anesthesia-related morbidity and mortality.
Repeated attempts of tracheal intubations can result in serious soft tissue injury and rapidly deteriorate into a life threatening "cannot intubate-cannot ventilate" (CICV) crisis. The guidelines suggested by the American Society of Anesthesiologists and the Difficult Airway Society for managing the unanticipated difficult airway recommend the performance of a cricothyrotomy(CTY) as the next step for a CICV scenario.
Cricothyrotomy is an infrequently performed life saving procedure when facing a difficult CICV airway.Previous studies quote, the incidence of the CICV scenario to be in the range of 0.01-2 per 10,000 cases. It is therefore imperative that anesthesiologists have the necessary knowledge and skills in successfully managing this life-threatening airway crisis. However, several studies demonstrated that many practicing anesthesiologists and anesthesia trainees (residents/fellows) are uncomfortable with the management of a CICV situation because it is such a rare event. A recent Canadian survey shows that only a quarter of the residents and 40% of practicing anesthesiologists were comfortable with performing a cricothyrotomy. Similar findings were reported in a German national survey of academic teaching hospitals where difficult airway situations, particularly a CICV crisis, were poorly managed and were postulated to have contributed to adverse patient outcomes.Complications of emergency CTY by physicians are common, with rates ranging from 9% to 40%.These complications include failure to cannulate the trachea, false airway passage, severe bleeding, posterior tracheal wall injuries, pneumothorax and esophageal laceration. All of these major complications may be related to improper identification of anatomical landmarks used to identify the correct position of cricothyroid membrane (CTM). The current method of CTY relies solely on digital palpation of these landmarks to accurately identify the CTM.
Several studies have identified independent predictors for patients with difficult airway. These include characteristics such as high body mass index, presence of beard, short bull neck, distorted neck anatomy either due to congenital or acquired pathology such as goiters or radiation to the neck. These are the same factors which may lead to improper identification of neck landmarks for the CTY.
The outcome and accuracy of CTY may be improved with better preparedness and pre-procedural identification of the neck landmarks for CTY before deciding the method of anesthetic. This is especially true in patients with anatomical features of difficult airway, who may be the ones more likely to have a difficult airway or require an emergency CT. In this patient population, incorrect localization of the CTM may lead to significant airway morbidity or failure to quickly establish an airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-III patients aged ≥ 18 with neck pathology who were scheduled for a neck CT scan at University Health Network. All patients recruited in the study had neck pathologies including previous neck surgery, irradiation and/or neck mass.
排除标准
- •patients who were unable to lie flat, unable to maintain a neutral neck position and those who refused to participate in the study.
研究组 & 干预措施
External Palpation group
External Palpation group will consist of 109 patients, who's CTM will be marked using traditional palpation technique of identifying the Cricothyroid membrane.
干预措施: External Palpation (Other)
Ultrasound group
Ultrasound group will consist of 114 patients, who's CTM will be marked using, ultrasonography to identify the CTM.
The Intervention by using the Ultrasound to determine the CTM.
干预措施: Ultrasound (Device)
结局指标
主要结局
accuracy in identification of the Cricothyroid Membrane
时间窗: Less than 1 min
accuracy in identification of the CM which was measured by a digital ruler in millimeter from the CT-point to the US-point or EP-point. We defined success as the proportion of accurate attempts within 5 mm distance from the CT-point to the US-point or EP-point.
次要结局
未报告次要终点
研究者
Dr. Naveed Siddiqui
Associate Professor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
