Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway in Spontaneously Breathing Patients Undergoing Elective Surgery Under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Success rate for the first attempt at insertion
研究概览
简要总结
Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.
详细描述
The study aims to compare the two devices with respect to:
Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (SpO2< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Sequentially numbered, sealed, opaque envelopes: Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Physical Status I & II
- •Patients undergoing limb or breast surgery
- •Patients undergoing elective surgery under general anesthesia and spontaneous ventilation.
- •Patients with expected duration of surgery of less than 2 hours.
排除标准
- •Patients with known or predicted difficult airway or Mallampati Grade (MPG) III or IV
- •Patients with mouth opening of less than 2.5 cm or cervical spine disease
- •Patients with H/o upper respiratory tract infection in the previous 10 days.
- •Patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.)
- •Patients with a body mass index (BMI) > 30 kg/m2
- •Patients with past history of radiotherapy involving the hypopharynx/neck area 7Patients with expected duration of surgery of more than 2 hours.
- •8.Surgery to be performed to the head, neck or thorax, abdomen or in the lateral or prone positions
研究组 & 干预措施
ProSeal Laryngeal Mask Airway
Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for PLMA insertion
干预措施: ProSeal Laryngeal Mask Airway (Device)
AmbuAuraGain Laryngeal Mask Airway
Intravenous (0.02mg/kg Midazolam and 2 microgram/kg Fentanyl) and oxygen via a face mask will be administered. Two minutes later, general anesthesia will be induced using 2 mg/kg intravenous Propofol mixed with 25 mg Lidocaine Injected over 30 seconds, Mask ventilation commence and continue for at least 30 seconds until conditions are suitable for AmbuAuraGain Laryngeal Mask Airway insertion
干预措施: AmbuAuraGain Laryngeal Mask Airway (Device)
结局指标
主要结局
Success rate for the first attempt at insertion
时间窗: 5 minutes
A failed insertion attempt is defined as when removal of the device needed from the mouth.
次要结局
- Time taken for insertion(5 minutes)
- The number of insertion attempts(5 minutes)
- Intracuff and the oropharyngeal leak pressures after ensuring effective placement.(5 minutes)
- The time taken for orogastric tube placement(5 minutes)
研究者
Dr.Deb Sanjay Nag
Consultant
Tata Main Hospital