Comparative Evaluation of Two Different Operator Positions on the Insertion Characteristics of Proseal Laryngeal Mask Airway in Patients Undergoing Elective Surgery under General Anaesthesia A Randomized Clinical Study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- PRIMARY OBJECTIVE
研究概览
简要总结
The study is a randomized clinical trial comparing two different operator positions for ProSeal Laryngeal Mask Airway (PLMA) insertion in patients undergoing elective surgery under general anesthesia.
Key Details- Title Comparative evaluation of two different operator positions on the insertion characteristics of ProSeal LMA in patients undergoing elective surgery under general anesthesia.
Patients: ASA I and II, modified Mallampati grading I and II, BMI 18-25 kg/m2.
Exclusions: Patients with anticipated difficult airway or at risk of aspiration.
Sample SizeN 60 patients.
Groups: Randomized into Group H (PLMA insertion from head end) and Group F (PLMA insertion from front).
Primary Objective Compare time taken for successful PLMA insertion in two operator positions.
Secondary Objectives Evaluate and compare first attempt success rate, overall success rate, ease of insertion, oropharyngeal leak pressure, fiberoptic view grading, and pharyngolaryngeal morbidity.
CTRI Registration Considerations- Trial Design Randomized clinical trial.
-
Intervention Comparison of PLMA insertion techniques.
-
Outcome Measures Time for insertion, success rates, ease, complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists (ASA) physical Status I and II Modified Mallampati grading I and II Body Mass Index (BMI) of 18-30 kg/m2.
排除标准
- •Patients with an anticipated difficult airway Patients at risk of aspiration.
结局指标
主要结局
PRIMARY OBJECTIVE
时间窗: 15-20 seconds
To evaluate and compare the time taken for successful insertion of PLMA in two different operator positions in patients undergoing elective surgery under general anaesthesia.
时间窗: 15-20 seconds
次要结局
- SECONDARY OBJECTIVES(To evaluate and compare:)
研究者
Hemlata Jangra
ESIC MEDICAL COLLEGE ,FARIDABAD