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临床试验/CTRI/2017/11/010452
CTRI/2017/11/010452已完成不适用

The comparison between supreme laryngeal mask airway and endotracheal tube with respect to adequacy of ventilation in patients undergoing laparoscopic cholecystectomy under general anaesthesia.

PD Hinduja National Hospital and Medical Research Centre1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2015年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
1
主要终点
Adequacy of ventilation

研究概览

简要总结

Hypothesis- Theventilation of patients is adequate with both Supreme Laryngeal Mask Airway (LMAS) and Endotracheal Tube (ETT) undergoinglaparoscopic cholecystectomy under general anesthesia. My question is whetherLMAS is better than or similar to ETT in the ventilation of the patient.

Rationale- Laparoscopic cholecystectomy is done under general anesthesia.Under general anesthesia the patient cannot breathe on his own, so we need toput in an airway device to mechanically ventilate his lungs.

Till date, the cuffed endotracheal tube was considered as the goldstandard for providing a safe seal in the larynx, especially for laparoscopicprocedures under general anesthesia. The disadvantages of tracheal intubation,which involves rigid laryngoscopy, are in terms of concomitant haemodynamicresponses and damage to the oropharyngeal structures at insertion.Postoperative sore throat is also a serious concern. This precludes the globalutility of the tracheal tube and requires a better alternative. Over a periodof time, new airway devices have been added to the anaesthesiologist’sarmamentarium.

Supreme laryngeal mask airway (LMAS) is a supraglottic device whichhas an advanced cuff to provide a better seal around the laryngeal opening and permits peak airway pressure more than 30 cm waterwithout leak. It has a drain tube parallel to theventilation tube which permits drainage of passively regurgitated gastric fluidaway from the airway and serves as a passage for gastric tube. The LMAS is single use, latex freeand is made of medical grade PVC. The firm, elliptical andanatomically shaped airway tube facilitates easy insertion, without placingfingers in the patient’s mouth or placing an introducer tool for insertion.

This study is therefore undertaken to see if LMAS provides betteror similar ventilation than ETT in healthy adult patients undergoinglaparoscopic cholecystectomy under general anesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •Consecutive 132 American Society of Anesthesiologists (ASA) status I and II adults of either sex, aged 20-65 years and body weight 40-80 kg, scheduled for elective laparoscopic cholecystectomy, under general anaesthesia, who had given consent to participate was recruited.

排除标准

  • •Patients with anticipated difficult airway, Obesity (body mass index >30 kg/m2), Oropharyngeal pathology, Cardiopulmonary disease, Cervical spine fracture or instability, Increased risk of aspiration.

结局指标

主要结局

Adequacy of ventilation

时间窗: From insertion of airway device to end of anaesthesia.

i) Quality of glottic airway seal – Difference between Inspired tidal volume and

时间窗: From insertion of airway device to end of anaesthesia.

Expired tidal volume

时间窗: From insertion of airway device to end of anaesthesia.

ii) Oxygen saturation

时间窗: From insertion of airway device to end of anaesthesia.

iii) EtCO2

时间窗: From insertion of airway device to end of anaesthesia.

iv) Peak airway pressures

时间窗: From insertion of airway device to end of anaesthesia.

次要结局

  • 2. Ease of Insertion(Time required for achieving effective airway and the number of attempts for securing)

研究者

发起方
PD Hinduja National Hospital and Medical Research Centre
申办方类型
Research institution and hospital

研究点 (1)

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