A Comparison of Ultrasound Versus Digital Palpation Guided Cricothyrotomy in Subjects With Poorly Defined Anatomical Landmarks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 主要终点
- The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries
研究概览
简要总结
Inability to provide oxygen to the patient remains the most fearful anesthesia-related mishap. Cricothyrotomy (CT) is an infrequently performed but life saving procedure for an anesthesiologist, who is encountered with this situation. The current method of cricothyrotomy relies on digital palpation (DP). Several patient populations, including morbidly obese, short neck, radiation to and previous neck surgeries, have difficult landmarks for this procedure. Ultrasound (US) technology has been used in the past to visualize landmarks for cricothyrotomy, but there is no study which has examined the role of ultrasound in patients who have obscure landmarks. There is no data related to the performance of ultrasound guided cricothyrotomy in these patients. In this study, we aimed to determine the outcomes of CT performed on human cadavers using US-guidance, compared to conventional DP, of anatomical landmarks. In particularly, complication rates, failure to cannulate, correct placement of the device and insertion time of CT were assessed.
详细描述
For each cadaver - epidemiological data (age, sex) and morphometric data (Body Mass Index, neck circumference, thyromental distance)
The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture)). For clinical relevance and analysis of data we dichotomized the scale to none-mild and moderate - severe injuries.
The secondary outcomes include: 1) insertion time, measured in seconds (s) from the time of palpation of the skin to insertion of the Portex device in the trachea; 2) failure, with a 'failure' defined as any attempt in which the trachea was not cannulated, or which required > 300 s to perform; and 3) correct land-marking, defined as having the Portex device inserted via the CM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residents who are novice to the application of ultrasound in difficult airway scenarios
- •Cadavers with difficult and imposible landmarks identification
排除标准
- •Anethesiologist with previous experience in CT, manual or ultrasound assisted
- •Patients with easily identifiable landmarks
结局指标
主要结局
The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries
时间窗: On avergae less than 300 seconds
The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (\< 5 mm laceration); moderate (\> 5mm laceration or partial puncture); severe (\> 10 mm laceration or full puncture)).
次要结局
- Number of Attempts(not more than 300 seconds)
- Correct Landmarking(less than 300 seconds)
- Insertion Time(less than 5 minutes from starting of procedure)
研究者
Dr. Naveed Siddiqui
Assistant Professor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital