Study of the Laryngopharyngeal Symptoms After Minimally Invasive Thyroidectomy: Comparison Between the Protector Laryngeal Mask Airway and the Endotracheal Tube.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Postoperative sore throat.
研究概览
简要总结
The patients will be allocated to 2 groups: the LMA group and the endotracheal tube (ET) group. Airway management will be done with the LMA Protector for the patients of the LMA group and with the classic endotracheal tube for the patients of the ET group. The main purpose of the study is to determine if the application of the LMA Protector causes less laryngopharyngeal symptoms than the endotracheal tube after minimally invasive thyroidectomy. The secondary purpose is to confirm that the LMA Protector is a safe alternative airway management device for minimally invasive thyroidectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total thyroidectomy with the minimally invasive method.
- •American Society of Anesthesiologists (ASA) classification 1-3
排除标准
- •Clinical conditions which cause any kind of airway obstruction or compromise.
- •Tracheal displacement greater than 2cm from midline.
- •History of gastroesophageal reflux disease.
- •Expected difficult airway.
- •History of impossible intubation.
- •Reoperation within 24hours.
研究组 & 干预措施
LMA Protector
After induction of general anesthesia, the LMA Protector will be applied for airway management. The size of the laryngeal mask will be chosen according to the manufacturer's instructions. Lubricant gel will be applied to the dorsal side of the mask to ease the insertion to the oropharynx. The cuff of the mask will be filled with air by syringe until the indication of the integrated cuff pressure indicator is appropriate according to the manufacturer (green indication). If the indication changes during surgery, air will be added or removed accordingly. If the ventilation of the patient is inadequate at the beginning or anytime during the operation, the mask will be removed and the patient will be intubated
干预措施: LMA Protector (Device)
Endotracheal tube
After induction of general anesthesia, the endotracheal tube be applied for airway management. The size of the tube will be 7.5 for female and 8.5 for male patients. The cuff of of the tube will be filled with 10ml air.
干预措施: Endotracheal tube (Device)
结局指标
主要结局
Postoperative sore throat.
时间窗: 24 hours after the exit from the recovery room.
The patients will be asked to evaluate their postoperative constant pharyngeal pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
Postoperative surgical site pain.
时间窗: 24 hours after the exit from the recovery room.
The patients will be asked to evaluate their postoperative surgical trauma pain by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
Postoperative dysphagia.
时间窗: 24 hours after the exit from the recovery room.
The patients will be asked to evaluate their postoperative pharyngeal pain caused after swallowing one sip of water by using the 11grade Numerical Rating Scale (0 no pain, 10 maximum possible pain).
次要结局
- Airway management difficulty.(3 minutes after induction of general anesthesia.)
- Airway management complications.(Within 5 minutes from induction of general anesthesia.)
- Postoperative paracetamol consumption.(1, 6, 12 and 24 hours after emergence from general anesthesia.)
- Emergence coughing.(Within 10 minutes from the end of the surgery.)
- Postoperative hoarseness.(Within 20 minutes from the end of the procedure and after 1, 6, 12 and 24 hours.)
研究者
Georgios Kotsovolis
Dr Georgios Kotsovolis
424 General Military Hospital