The Effect of Supraglottic Airway Insertion on the Accuracy of Cricothyroid Membrane Identification in Females- a Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- accurate identification of the cricothyroid membrane
研究概览
简要总结
Prospective, observational, study that will examine if a sited supraglottic airway (the igel) will increase the accuracy of identifying the cricothyroid membrane in female patients.
Consented patients that meet inclusion criteria are assessed by clinicians under general anaesthesia with and without a supraglottic airway in situ. The accuracy of CTM identification by palpation will be evaluated using ultrasound.
详细描述
Palpation of the airway structures results in misidentification of the cricothyroid membrane (CTM) in a high proportion of women. Female front of neck anatomy is less distinct compared to males with reduced angulation of the laryngeal cartilages making it harder to distinguish the relevant landmarks. In obese patients, overlying subcutaneous tissue compounds this problem and several studies have demonstrated poor success identifying the CTM by palpation in this population. Supraglottic airway device (SAD) insertion precedes emergency front of neck access attempts in the stepwise progression from failed intubation to cricothyroidotomy. The nature and clinical implication of SAD insertion on cricothyroidotomy remain unstudied.
Sixty four patients will undergo front of neck airway assessment by volunteer clinicians with and without a SAD in situ (control and SAD assessments, within-subjects design). The patients are fasting women presenting for routine gynaecological surgery. Eight anaesthetists, at different levels of training, will perform eight individual CTM assessments with and without the SAD in situ.
Ultrasound images will be captured in the sagittal plane immediately before and after supraglottic airway insertion. Images are then downloaded, anonymised and randomised for blinded digital analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women attending for routine surgery
排除标准
- •unable to give informed consent
- •abnormal neck anatomy
- •history of gastroesophageal reflux
- •history of neck surgery or radiotherapy
- •contraindication to supraglottic airway device insertion
结局指标
主要结局
accurate identification of the cricothyroid membrane
时间窗: At clinician assessment, on the day of patient recruitment.
accuracy of cricothyroid membrane identification, measured as either successful identification or unsuccessful (binary outcome). A successful identification is within 5mm of the midline and within the upper and lower borders of the cricothyroid membrane as measured using ultrasound.
次要结局
- The distance from the skin to the first tracheal ring(On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment)
- Accurate identification of the midline of the neck(At clinician assessment, on the day of patient recruitment.)
- Difficulty of cricothyroid membrane assessment(At clinician assessment, on the day of patient recruitment.)
- Time taken to attempt localisation of the cricothyroid membrane(At clinician assessment, on the day of patient recruitment.)
- The angle between the surface tissue interface of the cricothyroid membrane and the trachea(On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment)
- Distance from clinician assessment to actual cricothyroid membrane location(On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment)
- The distance from the skin to the cricoid cartilage(On blinded, retrospective ultrasound analysis of images captured at the time of clinician assessment of the cricothyroid membrane. Blinded retrospective ultrasound assessment is to take place within 3 months of patient recruitment)
研究者
Tom Drew
Principal Study Investigor, SpR Anaesthetist
The Rotunda Hospital