Continuous Endotracheal Cuff Pressure Monitoring vs Conventional Pilot Balloon Palpation Method on incidence of Postoperative Sore Throat (POST) in intubated patients- A Quasi Experimental Controlled Before and After (CBA) Study.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate & compare the incidence of postoperative sore throat (POST) within 24 hrs of intubation in patients with continuous cuff pressure monitoring versus the conventional palpation method.
研究概览
简要总结
Participants will include patients undergoing elective surgeries requiring general anesthesia with endotracheal intubation. This prospective quasi experimental controlled before and after study will allocate the first 40 patients to Group A and the next 40 patients to Group B, without randomization. Because of the nature of the intervention, the anesthesiologist cannot be blinded, but the outcome assessors and patients will remain blinded to group allocation.
A standardized general anesthesia protocol will be followed for all participants. After fasting as per guidelines and receiving routine premedications, patients will undergo induction with fentanyl, propofol, and rocuronium, followed by endotracheal intubation with a cuffed PVC tube. Cuff inflation techniques will differ between groups. Group A will use pilot balloon palpation based on audible leak, while Group B will have cuff pressure continuously monitored and maintained between 20 to 30 cm H2O at 15 minute intervals. Anesthesia maintenance will include oxygen air mixture with sevoflurane, and muscle relaxation will be maintained with intermittent rocuronium dosing. Sugammadex will be used for reversal at the end of surgery, and postoperative analgesia will include intravenous paracetamol.
Patients requiring more than two intubation attempts will be excluded. Postoperative assessments including sore throat, nausea, vomiting, cough, and hoarseness will be performed at 0, 2, 4, 12, and 24 hours by blinded assessors. Total intubation duration will also be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Adults aged (18–65) years ASA physical status (I.
- •III) American Society of Anesthesiologists (ASA)classification Modified Mallampati Grade (I-III) Expected duration of intubation more than 1 hour Elective surgery under endotracheal intubation BMI (19-30) kg per m2.
排除标准
- •More than two attempts of intubation Patients with preoperative cough, sore throat, smoking, airway disease like COPD Patients with preoperative nasogastric tube in situ Previous history of Throat, Laryngeal, or Tracheal Surgery Pregnancy Use of nitrous oxide.
结局指标
主要结局
To evaluate & compare the incidence of postoperative sore throat (POST) within 24 hrs of intubation in patients with continuous cuff pressure monitoring versus the conventional palpation method.
时间窗: (0, 2, 4, 12 and 24) hour
次要结局
- To evaluate other complications within 24 hours of extubation:(postoperative nausea & vomiting (PONV),)
研究者
RAJU SHAKYA
NEIGRIHMS (North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences)
