Comparison of intracuff pressure of Endotracheal tube with three different devices
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- To compare the intracuff pressures of endotracheal tube using three different devices at different moments of time during surgical procedures
研究概览
简要总结
All patients who will be provided general anaesthesia for any surgery will be included in this study. Standard general Anaesthesia will be administered. Premedication as per surgical procedure will be given.
General anesthesia will be induced using an intravenous propofol 2mg/kg; neuromuscular blockade will be achieved with inj. Vecuronium bromide 0.1mg/kg and then as per requirement. Male patients will be intubated with an 8 or 8.5 mm internal diameter PVC ETT, and female patients with a 7.0 or 7.5 mm internal diameter PVC ETT. Anesthesia will be maintained with sevoflurane in a combination of air and oxygen.
As soon as the ETT is inserted, the ETT cuff will be inflated with air through Cuff pressure guage appropriately mentioned in the dial i.e 25 cm water. The Cuff pressure guage will be attached to the pilot balloon with three way connector. If the ETT intracuff pressure is more than or less than 25 cm of water then it will be adjusted to 25 cm.
Immediately, at same time (0 min.), the intracuff pressure will be measured with AGCUFFILL device and then with Cuffsure device. The readings will be noted. After every 30 minutes, similarly the ETT intracuff pressure will be measured and readings will be compared statistically till 2 hours of surgical procedures. At any moment of time if the reading with Cuff pressure guage measures more than or less than 25 cm of water, the reading will be adjusted to 25 cm of water and further it will be measured by both other devices. The readings will be noted at 0 min., 30 min., 60 min. 90 min. and 120 minutes with all three devices and the Intracuff pressure readings will be noted.
The hemodynamics like heart rate, non-invasive BP, SPO2 and EtCO2 will be measured at this moments of time i.e at 0 min., 30 min.,60 min. and 120 minutes.
The mean of the intracuff pressures and mean of the heart rate, Mean blood pressure, Mean SPO2 and Mean EtCO2 will be compared with appropriate statistical tests.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 18 and above where ETT intubation will be done Patients who are willing to give consent.
排除标准
- •Those with anticipated difficult intubation History of difficult intubation Patients with high risk of aspiration Known anatomical laryngotracheal abnormalities Emergency intubation will be excluded ETT intubation with tubes other than PVC tubes Duration of surgery more than 2 hours.
结局指标
主要结局
To compare the intracuff pressures of endotracheal tube using three different devices at different moments of time during surgical procedures
时间窗: 0 min,30 min, 60 min, 90 min, 120 min
次要结局
- To measure the hemodynamics at different moments of time when intracuff pressures are measured with all the three devices(0 min,30 min, 60 min, 90 min, 120 min)
研究者
Deepak Longia
Government Medical College and Hospital, Chandigarh