Comparision of Flexi-slip stylet, Introducer tool and Standard digital technique of Proseal Laryngeal Mask Airway(PLMA) insertion-A randomized control 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
- To estimate the first attempt insertion success rate
研究概览
简要总结
This is a prospective, randomized clinical study involving 120 adult patients undergoing elective surgery under general anaesthesia. After obtaining ethical clearance, CTRI registration, and informed written consent, patients will be randomly divided into three groups (n=40 each) to compare different techniques of ProSeal Laryngeal Mask Airway (PLMA) insertion:
- Group A: Insertion using a flexi-slip stylet.
- Group B: Standard digital insertion technique.
- Group C: Insertion using a metal introducer.
All patients will receive standard preoperative assessment and monitoring. Anaesthesia will be induced with glycopyrrolate, midazolam, fentanyl, propofol, and succinylcholine. Appropriate PLMA size will be selected based on weight. A maximum of three insertion attempts will be allowed before declaring failure.
Primary parameters assessed include insertion time, ease of insertion, number of attempts, and haemodynamic changes at various time points (baseline, immediately after insertion, and at 1, 5, and 10 minutes post-insertion). Complications such as blood on PLMA, aspiration, nausea, vomiting, and sore throat will be recorded.
The study aims to evaluate and compare the success rate, ease, and safety of three different PLMA insertion techniques.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •A) Patients undergoing elective surgeries under general anaesthesia for moderate duration (up to two hours) in supine position.
- •B) Adult patients between 18-60 years of age.
- •C)American society of Anaesthesiologist’s (ASA) -classification I-II.
- •D)Patients giving informed written and valid consent.
排除标准
- •Patient requiring mechanical ventilation following surgery Inadequate nil by mouth status Pregnant women Limited mouth opening Patient who had upper respiratory tract infection with in past week.
- •Obese patient with body mass index more than 30kg/m2 Patient of upper airway pathology Chronic obstructive pulmonary disease, bronchial asthma, active airway disease.
- •Patient having history of oesophageal or gastric surgeries.
- •Head and neck surgery.
结局指标
主要结局
To estimate the first attempt insertion success rate
时间窗: baseline time T0-at the time of insertion
次要结局
- A) To determine ease of insertion(i. Grade 1:Smooth(no resistance))
- A) To estimate time taken for insertion using each of the techniques.
- To evaluate hemodynamic stability during insertion(• P1-baseline measurement,)
研究者
DR SHILPA H M
KMC-RI hubli