COMPARATIVE STUDY BETWEEN TWO SUPRAGLOTTIC AIRWAY DEVICES IN ANAESTHETISED, SPONTANEOUSLY VENTILATED ADULT PATIENTS DURING ELECTIVE SURGICAL PROCEDURES
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PRIMARY OBJECTIVES
研究概览
简要总结
Maintenance of airway with minimal complications is utmost priority of anaesthesiologist during anaesthesia to provide adequate ventilation to the patient. Endotracheal intubation is the gold standard method for this purpose, but some undesirable complications are associated with it e.g, haemodynamic instability as it requires laryngoscopy.
Laryngeal Mask Airway(LMA) has revolutionized airway management and is an excellent alternative to mask ventilation and tracheal intubation during General Anaesthesia (GA).
I-gel has been designed to improve efficacy in terms of airway-seal and safety in terms of protection from gastric aspiration which is not seen in Classic LMA (CLMA). They are easily inserted, better-tolerated with lesser haemodynamic changes, have favorable respiratory mechanics and decreased airway morbidity with minimal risk of tissue compression. As the elimination of cuff inflation shorten insertion-time, it is advantageous to be used during Cardio Pulmonary Resuscitation (CPR) by non-anaesthetists and in emergency situations requiring prompt airway care in which time is very-important.
Therefore,this prospective, randomised,comparative study will be carried out in 100 anaesthetised spontaneously breathing adult patients of both genders, aged between (15-60) years with American Society of Anesthesiologists (ASA) physical status I or, II and Mallampatti grade I or II, posted for elective surgeries under General Anaesthesia (GA) using either the I-gel or, Classic LMA (CLMA) at operation theatres in KPC MEDICAL COLLEGE AND HOSPITAL for 2 years. We will compare the safety and efficacy of I-gel and CLMA regarding the device-insertion parameters (like, insertion time, number of insertion attempts and ease of insertion), perioperative haemodynamic parameters like Heart Rate, Non invasive Blood Pressure, Oxygen saturation (SPO2) and End tidal CO2 (EtCO2) due to device insertion. Appropriate statistical methods will be applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA The surgical procedures taken into consideration are 1)Adult patients of either sex aged between (15-60) years.
- •American Society of Anaesthesiologists (ASA) grade I-II 3)Mallampatti (MP) grade I and II 4)Body Mass Index (BMI) between (20-25) kg/m² 5)Scheduled for elective surgeries under general anaesthesia, not requiring muscle relaxation.
排除标准
- •EXCLUSION CRITERIA The following patients will be excluded from the study 1)Age < 15 years and > 60 years.
- •American Society of Anaesthesiologists (ASA) grade III and IV 3)Mallampatti (MP) grade 3 and 4 4)Patients having any abnormality of the neck, anticipated difficult airway.
- •Mouth opening < 2 cm.
- •Upper respiratory tract infection.
- •History of Obstructive Sleep Apnoea.
- •Obese patients with Body Mass Index (BMI) > 28 kg/m² 9) Patients with increased risk of aspiration.
- •Duration of surgery > 1 hour.
- •Pregnant females.
- •Patients with reported history of hypersensitivity for one or more medications and latex.
结局指标
主要结局
PRIMARY OBJECTIVES
时间窗: 2 years
2)Number of insertion attempts.
时间窗: 2 years
To study and compare two supraglottic airway devices, I-gel and Classical laryngeal mask airway, in anaesthetized adult patients with spontaneous ventilation during elective surgical procedures, with respect to
时间窗: 2 years
1)Time taken for insertion.
时间窗: 2 years
3)Ease of insertion, any manipulations required.
时间窗: 2 years
次要结局
未报告次要终点