Scheduled Manometer-Guided Endotracheal Tube Cuff-Pressure Management Versus Pilot-Balloon Palpation for Reducing Postoperative Sore Throat in Adults Undergoing Elective Surgery With Tracheal Intubation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Occurrence of Postoperative Sore Throat Within 24 Hours
研究概览
简要总结
This randomized controlled trial evaluated whether scheduled measurement and adjustment of endotracheal tube cuff pressure using a handheld manometer could reduce postoperative sore throat in adults undergoing elective surgery under general anesthesia with tracheal intubation.
Participants were randomly assigned in a 1:1 ratio to either manometer-guided cuff-pressure management or conventional cuff inflation based on pilot-balloon palpation. In the manometer-guided group, cuff pressure was maintained within a target range of 25-30 cmH₂O. In the conventional group, cuff inflation was managed according to the attending anesthesiologist's usual clinical assessment.
Cuff pressure was assessed at predefined time points during anesthesia. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation. Other postoperative airway symptoms, including hoarseness, difficulty swallowing, cough, and postoperative nausea or vomiting, were also assessed.
The main objective was to determine whether scheduled manometer-guided cuff-pressure management reduced the occurrence of postoperative sore throat within the first 24 hours after surgery compared with conventional pilot-balloon palpation.
详细描述
This was a prospective, randomized, parallel-group controlled trial conducted in adults undergoing elective surgery under general anesthesia with planned endotracheal intubation.
Eligible participants were randomized in a 1:1 ratio to one of two cuff-pressure management strategies.
In the manometer-guided group, endotracheal tube cuff pressure was initially adjusted to a target range of 25-30 cmH₂O using a calibrated handheld cuff manometer. Cuff pressure was subsequently assessed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. At each scheduled assessment after the initial adjustment, cuff pressure was recorded before adjustment and was readjusted to 25-30 cmH₂O when necessary.
In the conventional pilot-balloon palpation group, cuff inflation was performed according to the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured using the same manometer at the predefined study time points for study documentation, but the measured values were not used to guide cuff-pressure adjustment.
Postoperative outcomes were assessed by an investigator blinded to treatment allocation. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation using a 10-point numerical rating scale. The primary outcome was the occurrence of any postoperative sore throat within 24 hours. Additional postoperative airway symptoms and cuff-pressure-related outcomes were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Postoperative outcomes were assessed by an investigator who was blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Scheduled for elective surgery under general anesthesia with planned endotracheal intubation.
- •Provided written informed consent.
排除标准
- •Active upper respiratory tract infection on the day of surgery.
- •Anticipated difficult airway.
- •Anatomical laryngotracheal abnormality.
- •Previous surgery or radiotherapy involving the laryngotracheal region.
- •Anticipated need for postoperative tracheal intubation lasting more than 24 hours.
研究组 & 干预措施
Manometer-Guided Cuff Pressure Management
Participants assigned to this arm underwent scheduled endotracheal tube cuff-pressure measurement using a handheld cuff manometer. Cuff pressure was initially adjusted to 25-30 cmH₂O and was reassessed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. At subsequent assessments, cuff pressure was readjusted to the target range when necessary.
干预措施: Handheld Endotracheal Tube Cuff Manometer (Device)
Pilot-Balloon Palpation
Participants assigned to this arm underwent conventional endotracheal tube cuff inflation based on the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured at the predefined study time points for study documentation only and was not used to guide pressure adjustment.
干预措施: Pilot-Balloon Palpation (Procedure)
结局指标
主要结局
Occurrence of Postoperative Sore Throat Within 24 Hours
时间窗: From 1 hour to 24 hours after extubation
Postoperative sore throat was assessed using a 10-point numerical rating scale (NRS) at 1, 6, and 24 hours after extubation. The primary outcome was defined as the occurrence of any postoperative sore throat within 24 hours, corresponding to an NRS score greater than 1 at any scheduled assessment.
次要结局
- Postoperative Sore Throat Severity at 1, 6, and 24 Hours(1, 6, and 24 hours after extubation)
- Postoperative Sore Throat Occurrence at Individual Time Points(1, 6, and 24 hours after extubation)
- Endotracheal Tube Cuff Pressure at Scheduled Intraoperative Time Points(Immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation)
- Proportion of Cuff Pressure Measurements Within the Target Range(Immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation)
研究者
Veysel Barış TURHAN
Associate Professor of General Surgery
Hitit University