Comparison of the BlockBusterTM and air-Q® supraglottic airway devices as a conduit to blind endotracheal intubation in paediatric patients: A randomised controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- percentage of successful blind endotracheal intubation in a single attempt.
研究概览
简要总结
Failure in the airway management and hypoxia can lead to irreversible brain damage within only a few minutes. Thus it is extremely important that there be methods for fast securing of the airway, in patients undergoing general anesthesia, that must be adequate for ventilation and oxygenation.
Rationale:
Complications related to the management of the pediatric difficult airway make it imperative to have a device that may facilitate blind intubation in difficult airway situations. According to a study conducted by Kleine-Brueggeney M et.al in 2015, Visualised blind intubation was possible in 15% with the air-Q® Masked Laryngeal Airways and in 3% with the AmbuAura-i. According to a study conducted in healthy adults, by Archana Endigeri et al. The first attempt success rate of blind tracheal intubation was 90% in BlockBusterTM LMA. The BlockBusterTM LMA demonstrated higher seal pressures than FASTRACH ILMA.
Aim: To determine the efficacy of laryngeal mask airways ( BlockbusterTM laryngeal mask airways vs air-Q® masked Laryngeal Airways) in acting as a conduit for successful blind endotracheal intubation in paediatric patients undergoing non emergency surgeries under general anaesthesia.
Objectives:
- Primary objective(s): To evaluate and compare the percentage of successful blind endotracheal intubation in a single attempt.
- Secondary objective(s): To evaluate and compare - The number of attempts required for successful placement of SAD, glottic view through fiberoptic bronchoscope, time required to successfully intubate the patient, incidence of peri and post procedural complications.
Methodology:
- Study design: A randomised controlled trial
- Sampling population: All patients (ASA 1 & 2) between age 6 months to 10 years coming to AIIMS Patna for elective surgical procedures requiring administering of general anaesthesia.
The study population will be divided into two groups.
Group 1:- This group will consist of patients in which air-Q® SAD will be used as a conduit for blind endotracheal intubation.
Group 2: This group will consist of patients in which BlockBusterTM SAD will be used as a conduit for blind endotracheal intubation.
Sample size : 80 (40 in each group)
Statistical analysis:- Categorical data will be expressed as frequency and percentage, and normally distributed continuous data will be reported as the mean with standard deviation, otherwise as median with quartiles. Parametric data will be compared using an unpaired tâ€test. Nonâ€parametric data will be compared with Fisher’s exact test or Chiâ€square test. Data will be presented as mean ± standard deviation with P < 0.05 as statistically significant.
There is no added risk in application of these devices.
This study would help in selecting a better SGA for blind intubation in a difficult airway scenario.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status I and II ages 6 months to 10 years weighing 5 to 30 kg patients undergoing elective surgeries under general anesthesia.
排除标准
- •Refusal by the guardian Anticipated difficult airway Children who had previously failed conventional direct laryngoscopy.
- •History of cardiopulmonary disease Weight-for-height greater than >3 standard deviations above WHO Child Growth Standards median( in age < 5 years) or BMI>30 (in age > 5 years) Presence of mass/lesion in the airway Patient posted for emergency procedures Head and Neck surgery Any surgical procedure with expected postoperative ICU admission.
结局指标
主要结局
percentage of successful blind endotracheal intubation in a single attempt.
时间窗: after placing lma followed by successful attempt of intubation will be recorded in the intraoperative period.
次要结局
- peak pressure, the number of attempts required for successful placement of SAD,the glottic view through fiberoptic bronchoscope, the time required to successfully intubate the patient.(To be assessed after securing supraglottic device and endotracheal intubation.The post anesthesia related problems are to be assessed after surgery in the post anaesthesia care unit and after 24 hours after.)