NCT05832944招募中不适用
Hyomental Distance Measured Ultrasonography Versus Weight-based Criteria for Laryngeal Mask Size Selection in Children. A Prospective, Randomised Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- correct size selection of LMA
研究概览
简要总结
- In pediatric surgery and emergencies, LMA represents a useful airway management device for routine and difficult airway management.
- Inserting an improper LMA size may result in malposition, displacement within the hypopharynx, and failed ventilation that needs repositioning.
- Selection of the size of LMA represents a major challenge for anesthesiologists, especially in children.
- The ultrasonographic measured hyomental distance showed a correlation with the length of the pharyngeal cavity.
- Optimization of the size of the inserted LMA can be confirmed either clinically, ultrasonographic or through the fiberoptic laryngoscope.
- The ultrasonographic measured hyomental distance confirmed the optimization of LMA with results comparable to that of the clinical methods and better than those of the fiberoptic laryngoscope.
详细描述
- The laryngeal mask airway (LMA) is classified as one of the supraglottic devices that have been extensively adopted as an adjunctive or alternative technique to tracheal intubation or mask ventilation for airway management in short-time surgery. Moreover, it is characterized by ease of placement and removal, less injury to the respiratory tract, better tolerability by patients, improved hemodynamic stability, less coughing, less sore throat, avoidance of laryngoscopy, and hands-free airway. However, it is not suitable to overcome functional airway problems and mechanical airway obstruction.
- Although the weight-based method was considered the traditional method for the selection of the optimal LMA size, a clinical practice viewed that this method is not always applicable as there is no linear correlation between the upper airway anatomy and body weight with the presence of usual individual anatomical variation.
- Fortunately, ultrasonography gave high-resolution images of the anatomic structures of the upper airway comparable to computed tomography and magnetic resonance imaging, Ultrasound measurements were applied for the hyomental distance and the hyomental distance ratio. Some studies revealed variable sensitivity and specificity.
- This prospective randomized controlled study will aim to assess the efficacy and safety of ultrasonographic measured hyomental distance in the optimization of the laryngeal mask(LMA)size selection and placement in pediatric patients Operational Design
A) Pre-anaesthetic management:
- Informed written parental consent will be taken from all participants.
- Medical history and complete clinical examination.
- Routine laboratory investigation including :
- CBC
- CRP
- INR, PT & PTT
- Patients will fast for at least 8 hours before surgery.
- Routine Monitoring, including heart rate (HR), oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) in the pre-anaesthesia room (Base Line Data).
- A peripheral intravenous line (24-22G) will be inserted.
- A premedication of 0.01 mg/kg Atropine will be administrated IM 1 hour before surgery.
B) Induction of general anaesthesia:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
double-blinded
入排标准
- 年龄范围
- 5 Years 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents' acceptance
- •Age: between 5-14 years
- •Physical Status: American Society of Anesthesiologists (ASA) I & II)
排除标准
- •Developmental Delay (mental and physical growth retardation).
- •Hypersensitivity to any type of used drugs.
- •Patient with a difficult airway ( according to thyromental height and the Mallampati test)
- •Patients with a history of neck surgery
- •Airway malformation.
- •Upper respiratory tract infection.
- •Surgeries that will take up to more than forty-five minutes.
结局指标
主要结局
correct size selection of LMA
时间窗: During LMA insertion (5 minutes duration)
* A five-point scale will be used to evaluate the ease of LMA insertion from 1 to 5, considering that 1 corresponds to (inserted without resistance) and 5 corresponds to (impossible to insert).
次要结局
- postoperative oral injury(After removal of LMA for 5 minutes)
- Values of oropharyngeal leak pressure (OLP) after airway management(During 30 minutes after LMA insertion)
- many insertion attempts(During LMA insertion attempts for 5 minutes)
研究者
AHMED ABDELAZIZ SHAMA
Assistant professor
Tanta University
研究点 (2)
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