Assessment of the Effects of Endotracheal Tube Temperature on Respiratory Complications in Children Undergoing Adenotonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Rate of laryngospasm
研究概览
简要总结
Adenotonsillectomy is one of the most commonly performed surgical procedures in children worldwide. life-threatening complications such as laryngospasm and bronchospasm may develop in the postoperative period.
The aim of this study was to compare the effects of using endotracheal intubation tubes at different temperatures during intubation on respiratory complications in the postoperative period in children undergoing adenotonsillectomy.
详细描述
Adenotonsillectomy (AT) is one of the most common surgical procedures performed in children. Its incidence has been increasing day by day and has almost doubled since the 1970s. In recent years, with the development of surgical techniques and anesthetic approaches, significant progress has been made in the recovery and postoperative management of these patients and morbidity has decreased significantly. The most feared complications of AT in children are respiratuar complications such as laryngospasm and bronchospasm. These complications can occur during AT or in the postoperative period, requiring rapid response by the anesthesia and surgical team and extensive postoperative monitoring. They may result in increased morbidity and prolonged hospitalization. Different methods including intravenous lidocaine, topical lidocaine, propofol, iv magnesium and the like have been proposed to reduce laryngospasm; different results have been obtained in studies. Thermal softening of endotracheal tubes (ETT) with normal warm saline before intubation has been shown to be significantly effective in reducing sore throat and hoarseness during recovery and postoperatively. The aim of this study was to compare the intraoperative and postoperative respiratory effects of using endotracheal intubation tubes at different temperatures during intubation in children undergoing adenotonsillectomy.
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
The patient and the outcomes assessor will not know the groups
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents who agreed to participate in the study
- •Children undergoing adenotonsillectomy
- •ASA 1 and 2 class patients
排除标准
- •Emergency surgery
- •Children with a history of difficult airway
- •Children who have had upper airway surgery
- •Presence or suspicion of upper or lower respiratory tract infection
- •History of cardiac and respiratory diseases
- •Patients with craniofacial malformations
研究组 & 干预措施
Group T37 (37°C Endotracheal tube)
Anesthesiologist will administer 0.02 mg/kg midazolam (Demizolam ®) for premedication 30 minutes before entering the operating room. The operating room temperature will be kept at 24°C. After entering the operating room, 1 mg/kg lidocaine (Aritmal ®), 2 mg/kg propofol (Propofol ®), 1 mcg/kg fentanyl (Fentanyl ®), 0.5 mg/kg rocuronium (Muscoblok ®) will be administered within the standard anesthesia induction protocol and the patients will be intubated by the anesthesiologist with age-appropriate endotracheal tube. After confirming the ETT location, the anesthesia device will be adjusted with age-appropriate respiratory rate and 6 l/kg tidal volume. Sevoflurane inhalation will be administered as 1 MAC for anesthesia maintenance. 10 mg/kg paracetamol will be administered to all patients for postoperative analgesia and 100 μg/kg Ondansetron for postoperative nausea and vomiting. At the end of surgery, 2mg/kg sugammadex will be administered for extubation.
干预措施: 37°C Endotracheal tube (Other)
Group T24 (24°C Endotracheal tube)
Anesthesiologist will administer 0.02 mg/kg midazolam (Demizolam ®) for premedication 30 minutes before entering the operating room. The operating room temperature will be kept at 24°C. After entering the operating room, 1 mg/kg lidocaine (Aritmal ®), 2 mg/kg propofol (Propofol ®), 1 mcg/kg fentanyl (Fentanyl ®), 0.5 mg/kg rocuronium (Muscoblok ®) will be administered within the standard anesthesia induction protocol and the patients will be intubated by the anesthesiologist with age-appropriate endotracheal tube. After confirming the ETT location, the anesthesia device will be adjusted with age-appropriate respiratory rate and 6 l/kg tidal volume. Sevoflurane inhalation will be administered as 1 MAC for anesthesia maintenance. 10 mg/kg paracetamol will be administered to all patients for postoperative analgesia and 100 μg/kg Ondansetron for postoperative nausea and vomiting. At the end of surgery, 2mg/kg sugammadex will be administered for extubation.
干预措施: 24°C Endotracheal tube (Other)
结局指标
主要结局
Rate of laryngospasm
时间窗: From extubation until postoperative 2. hour
The rates of laryngospasm occurring in the participants will be determined and compared between the 2 groups
Rate of bronchospasm
时间窗: From extubation until postoperative 2. hour
The rates of bronchospasm occurring in the participants will be determined and compared between the 2 groups
Rate of desaturation
时间窗: From extubation until postoperative 2. hour
The rates of desaturation occurring in the participants will be determined and compared between the 2 groups
次要结局
- Heart rate(7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care))
- Mean arterial pressure (MAP) mmHg(7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care))
- Oxygen saturation(7 times (1 minute(min) before induction of anaesthesia, 5 seconds(sec) after intubation, 5 min and 15 min after the start of surgery, 5 sec after the completion of surgery, 5 sec after extubation, 5 sec before transfer to post-anaesthesia care))
- Intraopearative anaesthesia machine respiratory data(4 times measurement (5 seconds after intubation, 5 minutes after the start of surgery, 15 minutes after the start of surgery, 5 seconds after the completion of surgery))
- Intraopearative anaesthesia machine respiratory data 2(4 times measurement (5 seconds after intubation, 5 minutes after the start of surgery, 15 minutes after the start of surgery, 5 seconds after the completion of surgery))
研究者
Mursel Ekinci
Assoc Prof
Bursa City Hospital