Comparative study to determine the efficacy of i-gel, BlockBuster, and Ambu Aura as ventilatory devices in short surgical procedures.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the oropharyngeal leak pressure for providing airway seal pressure of i-gel, BlockBuster, and Ambu Aura.
研究概览
简要总结
The present study is a Prospective, Randomized and Comparative study done after approval of Institutional Ethics Committee in patients satisfying all inclusion and exclusion Criteria planned for short surgeries under GA. Material used were i-gel, Ambu aura, Blockbuster, Anaesthesia workstation, suction apparatus, Laryngoscope and ET Tubes of various sizes. After careful preoperative assessment of all patients’ standard monitors including NIBP, ECG, and pulse oximeter will be attached to the patient.
The study population is divided into three groups of 30 each. Group i used i-gel , Group A used Ambu Aura, Group B used Blockbuster as ventilatory device.
In the operating room, an 18G IV cannula is inserted into both hands. Ringer lactate solution is infused at 10ml/kg. Patients receive 100% oxygen for 3 minutes, followed by premedication. Standard monitoring is connected. Anesthesia is induced with propofol and vecuronium and maintained with oxygen, nitrous oxide, and sevoflurane after introducing allocated SAD.
parameters like-successful insertion time, number of attempts of insertion, oropharyngeal leak pressure and vitals like- pulse rate, blood pressure, SpO2, EtCO2 and ventilator parameters will be noted before induction of anesthesia, throughout surgery and immediately after removal of the device after completion of surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •1.Patients giving informed written consent for participation in the study.
- •2.Patients posted for short surgeries (less than 90mins) under general anesthesia.
- •3.Age of the patient between 18-65 of either sex.
- •4.Patients belonging to American Society of Anesthesiologists- physical status I or II.
- •5.Patients belonging to Modified Mallampati class I and II.
排除标准
- •1.Patients with predicted difficult airway such as mouth opening less than 2 cm, (oropharynx, larynx) pathology.
- •2.Patients with head injury, psychiatric disorder, respiratory tract, endocrine disorder, patients with risk of regurgitation such as gastroesophageal reflux disease, hiatus hernia, esophageal varices, pregnant patient etc.
- •3.Patient who are obese (BMI more than 35 kg/m2).
结局指标
主要结局
To compare the oropharyngeal leak pressure for providing airway seal pressure of i-gel, BlockBuster, and Ambu Aura.
时间窗: After 5 minutes of positioning and fixation of the device, oropharyngeal leak pressure will be assessed. It will be measured by palpable or audible leak of gas in suprasternal notch and auscultation of epigastrium after closing the expiratory valve of the circle system to 30 cm of H2O at a fixed gas flow (only O2) of 6 L/min and airway pressure at steady state noted on the visual pressure gauge included in modern anesthesia machines. We will not permit it to exceed 30 cm of H2O.
次要结局
- To compare effective airway insertion time, number of insertions attempts and ease of insertion of device and gastric tube.
- To compare hemodynamics & ventilatory parameters, intraoperative & post-operative complications (oral trauma, sore throat, dyspnea etc.) during use of the devices, if any(Vital parameters like pulse rate, blood pressure, SpO2, EtCO2, & ventilator parameters will be noted at baseline (0 minutes) after induction of anesthesia, after insertion, 10 minutes after insertion, & immediately after removal of the device & after completion of surgery.)
研究者
Ashish Bisht
Government medical college, Haldwani