The Impact of Endotracheal Cuff Pressure Assessment Using a Cuff Pressure Manometer Compared With the Traditional Palpation Method on Postoperative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Incidence of Postoperative Airway-Related Complications
研究概览
简要总结
The aim of this prospective observational study is to evaluate the effect of endotracheal cuff pressure management on postoperative complications in patients undergoing surgery under general anesthesia. Specifically, patients whose endotracheal cuff pressure is maintained at an optimal level using a manometer will be compared with those whose cuff pressure is assessed using the conventional palpation method.
The primary question the study aims to answer is whether maintaining endotracheal cuff pressure at an optimal level with a manometer reduces the incidence of postoperative airway-related complications compared with the classical palpation technique.
详细描述
Endotracheal intubation is routinely performed in patients undergoing surgery under general anesthesia. Maintaining appropriate endotracheal tube cuff pressure is critical to ensure adequate ventilation, prevent aspiration, and minimize tracheal mucosal injury. Excessive cuff pressure may compromise tracheal mucosal perfusion and increase the risk of postoperative airway-related complications such as sore throat, hoarseness, cough, dysphagia, and laryngospasm. Conversely, insufficient cuff pressure may lead to air leakage and aspiration risk.
In routine clinical practice, cuff pressure is frequently assessed using conventional subjective methods such as manual palpation of the pilot balloon. However, this technique does not provide an accurate measurement and may result in pressures outside the recommended safe range (20-30 cmH₂O). Direct measurement using a manometer allows objective monitoring and adjustment of cuff pressure within the optimal range, potentially reducing airway mucosal damage and postoperative laryngeal complications.
This prospective observational study aims to compare two approaches to cuff pressure management in adult patients undergoing elective surgery under general anesthesia with endotracheal intubation:
Patients whose cuff pressure is measured and maintained within the optimal range using a manometer
Patients whose cuff pressure is assessed using conventional methods such as palpation
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-75 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Body mass index (BMI) between 18 and 30 kg/m²
- •Undergoing surgery under general anesthesia
- •Successful endotracheal intubation on the first attempt -Provided written informed consent and willing to participate in the study-
排除标准
- •Patients younger than 18 years or older than 75 years
- •American Society of Anesthesiologists (ASA) physical status IV-VI
- •Patients undergoing head and neck surgery
- •History of chronic pulmonary disease (e.g., asthma, chronic obstructive pulmonary disease)
- •Presence of preoperative sore throat
- •History of upper or lower respiratory tract infection within the past 2 weeks
- •Use of systemic steroids in the preoperative period
- •More than one attempt required for endotracheal intubation
- •Emergency surgeries
- •Refusal to participate in the study
研究组 & 干预措施
Manual Palpation
Patients whose endotracheal cuff pressure was maintained using the manual palpation method.
Cuff Pressure Manometer
Patients whose endotracheal cuff pressure was maintained using the cuff manometer method.
结局指标
主要结局
Incidence of Postoperative Airway-Related Complications
时间窗: Postoperative day 1
Presence of postoperative sore throat, hoarseness, dysphagia, cough, or laryngeal edema.
次要结局
- Severity of Postoperative Sore Throat(1 hour, 6 hours and 24 hours after extubation.)
- Incidence of Hoarseness(Postoperative day 1)
- Incidence of Dysphagia(Postoperative day 1)
- Measured Endotracheal Cuff Pressure(Intraoperative - immediately after intubation)
- Duration of Intubation(Intraoperative period (from intubation to extubation))
- Length of Post-Anesthesia Care Unit (PACU) Stay(Postoperative period - from PACU admission to PACU discharge (same day of surgery).)
研究者
Ezgi Abay
Anesthesiology and Reanimation Assistant Doctor
University of Gaziantep