Comparison of Fibreoptic guided tracheal intubation through Laryngeal mask airway Protector and Laryngeal mask airway Blockbuster in adult patients in general anaesthesia - A Randomized Comparitive Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Compare the time required for successful intubation through LARYNGEAL MASK AIRWAY Protector and LARYNGEAL MASK AIRWAY Blockbuster
研究概览
简要总结
INTRODUCTION Maintenance of airway is an integral part of general anaesthesia. Various airway devices are used for this purpose. Endotracheal tube (ETT) is the gold standard for maintenance of airway .
Second-generation supraglottic airway devices (SADs) are used for ventilation and as conduit for fiberoptic guided tracheal intubation (FGI).
The supraglottic airway devices LARYNGEAL MASK AIRWAY BlockBuster and LARYNGEAL MASK AIRWAY Protector are improved second-generation LMAs with intubation function
In the literature search, we did not find any report comparing the clinical performance of LARYNGEAL MASK AIRWAY Blockbuster with LARYNGEAL MASK AIRWAY Protector.
Hence, the present study is planned to compare the clinical performance of these LMA’s in patients undergoing elective surgery requiring general anaesthesia with endotracheal intubation
OBJECTIVES
PRIMARY OBJECTIVES To compare the time required for successful intubation through LARYNGEAL MASK AIRWAY Protector and LARYNGEAL MASK AIRWAY Blockbuster (measured from picking up of the device to the appearance of the first capnography trace)
SECONDARY OBJECTIVES To compare the number of attempts required for successful intubation in both groups 2. To compare the Grading of glottic view by Brimacombe and Berry scoring
METHODOLOGY
This study will be conducted in the Dept of Anaesthesiology , GIMS ,Greater Noida
Adult patients of ASA I and II class undergoing elective surgery requiring general anaesthesia with neuromuscular blockade aged 18 to 65 years old having BMI of 18-35 Kg/M2
SAMPLE SIZE
. Based on previous data, the mean time of insertion of the Laryngeal Mask Airway (LMA) was 12.2 seconds (SD = 1.5) in Group LB and 13.94 seconds (SD = 4.56) in Group LP, yielding an estimated effect size (Cohen’s d) of 0.5126. With a significance level of 0.05, desired power of 0.80, and an equal allocation ratio of 1:1 between the groups, the required total sample size was calculated to be 122 participants, with 61 participants in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients undergoing elective surgery requiring GA with neuromuscular blockade ASA 1 AND ASA 2 grade patients having BMI 18-30 KG/M2.
排除标准
- •Patients with known difficult airways (mouth opening less than 2.5cm, Mallampati class 3 and 4, cervical spine deformities, neck and jaw deformities).
- •BMI more than 30 Kg/m2 Patient with history of Gastro-oesophageal reflux disease Pregnant females Bleeding and clotting abnormalities Patient with history of upper Gastrointestinal bleed Patient getting operated for airway surgeries.
结局指标
主要结局
Compare the time required for successful intubation through LARYNGEAL MASK AIRWAY Protector and LARYNGEAL MASK AIRWAY Blockbuster
时间窗: after Successful intubation i.e in minutes at 5 min, 10 min, 15 min, 20 min
次要结局
- To compare the number of attempts required for successful intubation in both groups(maximum of two attempts will be allowed at 15 min, 20 min, 25 min)
研究者
Dr Aarth Aggarwal
Government Institute of Medical Science, Greater Noida