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临床试验/NCT06043648
NCT06043648已完成不适用

The Role of Continuous Endotracheal Tube Cuff Pressure Monitoring With a Simple Method in the Incidence of Endotracheal Tube-related Complications

Cukurova University1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
195
试验地点
1
主要终点
Incidence of postoperative dysphagia

研究概览

简要总结

Tracheal tube cuff pressure in the range of 20 to 30 cmH2O is considered safe, but it is quite common to encounter cuff pressure outside this range in patients with tracheal intubation. Moreover, objective cuff pressure measurement and monitoring are not routinely applied, especially in general anesthesia practice. Overinflation of the cuff can potentially impair tracheal mucosal blood flow. This may lead to various tracheal injuries such as mucosal inflammation, mucosal ischemia, tracheal ulceration, tracheal stenosis, tracheoesophageal fistula, and tracheal rupture. Conversely, inadequate cuff inflation can lead to inadequate ventilation and microaspiration. The importance of routine cuff pressure measurement and pressure adjustment to keep the pressure in the desired range is emphasized in preventing such side effects in intubated patients. Despite this recommendation for routine intracuff pressure measurement, the methods used to measure and monitor cuff pressure vary from subjective estimation techniques to objective measurements, and there is a lack of specific protocols and documents in the current literature. For this purpose, in this study, it was aimed to perform continuous cuff pressure measurement monitoring using the transducer of the invasive pressure monitoring device, which is routinely used in arterial or central venous pressure monitoring, and to test the effectiveness of this method in reducing cuff-related complications including sore throat, hoarseness, and dysphagia compared to the intermittent monitoring method.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years of age adult patients
  • Elective non-head-neck surgical procedures under nitrous oxide (N2O)-free general anesthesia
  • Patients orally intubated with a cuffed endotracheal tube facilitated by neuromuscular blockers
  • Surgeries with neutral head-neck position

排除标准

  • Emergency surgery
  • Laparoscopic surgery
  • Head and neck surgeries including nose, mouth, pharynx, larynx and throat
  • Surgeries with non-supine patient position
  • Patients with preoperative sore throat, cough, hoarseness or dysphagia, history of smoking, asthma or COPD, severe cardiovascular disease, inability to obtain consent, having any lesions detected in the pharynx or larynx during laryngoscopy
  • Use of double lumen tracheal tube
  • Use of a naso- or orogastric tube or any pharyngeal catheter
  • Intraoperative nitrous oxide use
  • Difficult intubation or repeated endotracheal intubation attempt
  • Patients who strain during endotracheal extubation
  • High PEEP (greater than 5 cmH2O) application

结局指标

主要结局

Incidence of postoperative dysphagia

时间窗: Postoperative 2 and 24 hours

The incidence of endotracheal tube-related complication defined as dysphagia during postoperative 2 and 24 hours.

Incidence of postoperative sore throat

时间窗: Postoperative 2 and 24 hours

The incidence of endotracheal tube-related complication defined as sore throat during postoperative 2 and 24 hours.

Incidence of postoperative hoarseness

时间窗: Postoperative 2 and 24 hours

The incidence of endotracheal tube-related complication defined as hoarseness during postoperative 2 and 24 hours.

次要结局

  • Identification of predictive factors related to endotracheal tube-related complications(During postoperative 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Demet Laflı Tunay

Principal Investigator

Cukurova University

研究点 (1)

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