跳至主要内容
临床试验/CTRI/2024/01/061573
CTRI/2024/01/061573招募中不适用

Comparison of Performance Characteristics of LMA ProSeal® and LMA BlockBuster® in Children Undergoing Surgical Procedures Under General Anaesthesia: A Randomized Control Study.

Sanjay Gandhi Postgraduate Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月20日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Oropharyngeal Leak Pressure will be measured as the primary outcome.

研究概览

简要总结

Airway management is one of the most essential and life-saving skills for an anaesthesiologist. There are several methods for airway management, but laryngoscopy and endotracheal intubation are considered the gold standard for securing the airway, however, it is difficult to learn and retain these skills. To overcome this problem classic Laryngeal mask airway (LMA classic) was introduced in 1983 by Archie Brain.LMA classic had limitations like a moderate pharyngeal seal and risk of regurgitation of gastric contents and aspiration with positive pressure ventilation. To overcome these limitations, a separate gastric channel was incorporated into the design of the classic and further several modifications led to the development of LMA ProSeal®.SADs have a lower risk of respiratory complications like throat pain, cough and dysphagia. Initially, LMA ProSeal® was introduced in adult sizes in the year 2001, later on Paediatric sizes were introduced in 2004. A meta-analysis conducted in 2017 found LMA ProSeal® to be the best supraglottic airway device for children as it has high oropharyngeal leak pressure and a low risk of insertion. The LMA BlockBuster® is a second-generation supraglottic airway device introduced in early 2012. Successful studies with LMA BlockBuster® have been carried out for controlled ventilation in adults with high oropharyngeal leak pressure (OLP). However, there is limited literature regarding the use of LMA BlockBuster® in paediatric patients. In this study, we aim to compare the performance characteristics of LMA ProSeal® and LMA BlockBuster® in children undergoing surgical procedures under general Anaesthesia. Seventy children aged between 1 year to 12 years with normal airways will be randomized into two groups using a computer-generated random number table. Inclusion Criteria: ASA I and II patients, Both male and female patients between 1-12 years, Elective procedures under General Anaesthesia. Exclusion Criteria: Parents/Patient attendant not giving consent, Weight less than 5 kg, Patients with BMI > 30 kg/m2, History of recent upper respiratory tract infection, Inadequate fasting, Patients with contraindications to SAD (restricted mouth opening, upper airway obstruction etc.), Patients with abnormal/distorted anatomy of the upper airway, Head, neck and oral surgery, Patients with increased risk of aspiration (GERD, Hiatus Hernia etc.), Emergency surgeries. After taking the patient to the operation theatre and administration of general anaesthesia, an appropriate size supraglottic airway will be inserted according to the age groups. Success and ease of supraglottic airway insertion, time of supraglottic airway insertion, oropharyngeal leak pressure, leak fraction, success and ease of gastric tube insertion, time of gastric tube insertion, and adverse effects were noted. The glottic view will be graded by fibreoptic scoring. Following surgery, residual neuromuscular paralysis will be reversed with neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg BW. The device will be removed when the patient will be awake and responsive. The patient will be inspected for any complications related to LMA insertion like -injury to lips, tongue, teeth and oropharyngeal tissues. On removal of the device presence of blood stain, will be noted. Cough, sore throat, change of voice, and dysphagia will be recorded (at 1h, 6h, 12h, and 24h).

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • ASA I and II patients.
  • Both male and female patients between 1-12 years of age.
  • Elective procedures under General Anaesthesia.

排除标准

  • 1.Parents/Patients attendant not giving consent.
  • 2.Weight less than 5 kg.
  • 3.Patients with BMI > 30 kg/m
  • 4.History of recent upper respiratory tract infection.
  • 5.Inadequate fasting.
  • 6.Patients with contraindications to SAD (restricted mouth opening, upper airway obstruction etc.).
  • 7.Patients with abnormal/distorted anatomy of the upper airway.
  • 8.Head, neck and oral surgery.
  • 9.Patients with increased risk of aspiration (GERD, Hiatus Hernia etc.).
  • 10.Emergency surgeries.

结局指标

主要结局

Oropharyngeal Leak Pressure will be measured as the primary outcome.

时间窗: Immediately after supraglottic airway device insertion.

次要结局

  • First-attempt and overall success rate of LMA insertion(2. Device insertion time)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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