The Effect of Intraoperative Endotracheal Tube Cuff Pressure on Postoperative Sore Throat in Pediatric Patients Undergoing Laparoscopic Appendectomy: A Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Sore Throat
研究概览
简要总结
Abstract Objective:
The aim of this study is to compare two different ways of adjusting the air-filled cushion (cuff) of the breathing tube used during general anesthesia in children undergoing laparoscopic appendectomy (closed surgery for appendicitis). The goal is to see if maintaining the pressure in this cushion within a safe, specific range (15-18 mmHg) helps prevent or reduce sore throat, hoarseness, and discomfort, which are common postoperative complications in children.
Study Design:
This is a prospective, randomized, controlled study. Sixty children aged 6 to 18 years scheduled for laparoscopic appendectomy will be included. Participants will be randomly assigned to two equal groups: Group A (Control Group): Breathing tube cuff pressure is adjusted using the standard "feeling" (finger palpation) method common in routine practice. Group B (Intervention Group): Breathing tube cuff pressure is measured throughout the surgery using a medical pressure sensor (manometer) and maintained within a safe range (15-18 mmHg). Research Questions: Does actively monitoring airway pressure reduce the number of children experiencing postoperative sore throat? Does this method reduce the severity of sore throat, cough, hoarseness, or other respiratory discomfort compared to the standard method? What will happen?
During surgery, respiratory and heart rate measurements will be recorded every 15 minutes for all participants. After surgery, researchers will visit participants (and their parents) at 2, 6, and 24 hours postoperatively to assess the presence of sore throat, discomfort, or hoarseness. No additional medications or invasive procedures will be used for this study; only how we manage airway pressure will be compared.
详细描述
Endotracheal tube (ETT) placement is a critical component of pediatric general anesthesia. In pediatric patients, the tracheal mucosa is highly sensitive to pressure. If the ETT cuff pressure exceeds the mucosal capillary perfusion pressure, it can lead to ischemic damage and subsequent postoperative airway morbidities such as postoperative sore throat (POST), cough, and hoarseness.
During laparoscopic surgeries such as appendectomy, the creation of pneumoperitoneum and the necessary surgical positioning increase intra-abdominal and intrathoracic pressures. These physiological changes dynamically increase the peak airway pressure (Ppeak) and the corresponding ETT cuff pressure, making optimal cuff pressure management clinically challenging.
Traditionally, cuff pressure is subjectively adjusted by the anesthesiologist using a pilot balloon palpation technique. However, evidence suggests that this method often leads to undetectable and unsafe high pressures. Alternatively, continuous objective monitoring of endotracheal tube (ETT) cuff pressure using an invasive arterial blood pressure transducer setup offers a real-time method for maintaining pressure within a safe physiological range (15-18 mmHg).
This prospective, randomized controlled trial aims to investigate whether continuous objective monitoring and titration of ETT cuff pressure via a pressure transducer, compared to conventional subjective palpation, can optimize intraoperative respiratory mechanics and reduce the frequency and severity of postoperative upper respiratory tract complications in pediatric patients undergoing laparoscopic appendectomy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study employs a single-blind design. The attending anesthesiologist performing the intraoperative procedure and data collection is aware of the group assignment (unmasked) to ensure correct intervention and monitoring. The principal investigator, who conducts all postoperative follow-up assessments, including sore throat scoring and airway complication evaluations, remains blinded to the patient's group allocation (masked) to prevent observer bias.
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 6-18 years
- •Patients with ASA physical status classification I-III
- •Patients scheduled for laparoscopic appendectomy
- •Voluntary written informed consent from the patient's legal guardian/parent after being informed in detail about the purpose and method of the study..
排除标准
- •Patients under 6 years of age
- •Patients with ASA IV or higher
- •Patients with preoperative sore throat
- •Patients who have not completed the preoperative fasting period
- •Patients who received intraoperative nasogastric tube
- •Patients who received intraoperative N₂O
- •Patients with complicated appendicitis diagnosis
- •Patients who underwent two or more intubation attempts
- •Patients with surgery duration longer than 2 hours
- •Patients with predicted or likely airway difficulties
- •Patients who underwent conversion from intraoperative laparoscopy to laparotomy
- •Presence of tracheal pathology
- •Congenital anomalies affecting the airway
- •Presence of known upper/lower respiratory tract disease
- •Patients requiring planned postoperative mechanical ventilation
- •Patients in shock
- •Patients with decompensated heart failure or respiratory failure
- •Patient or legal representative's refusal to participate in the study
- •Patients with a history of smoking
研究组 & 干预措施
Control Group
In this group of patients, endotracheal tube cuff pressure was adjusted using the traditionally used and subjective finger palpation technique of the endotracheal tube pilot balloon.
干预措施: Traditional Palpation Method (Procedure)
Intervention Group
In this group of patients, endotracheal tube cuff pressure was continuously monitored using a pressure transducer from an invasive arterial pressure measurement set and maintained within a safe range (15-18 mmHg).
干预措施: Pressure Transducer (Device)
结局指标
主要结局
Incidence of Postoperative Sore Throat
时间窗: 24 hours postoperatively
The incidence of sore throat in patients during the first 24 hours after surgery will be evaluated and compared between groups. Sore throat is defined as pain or discomfort felt in the larynx or pharynx, often worsened by swallowing. It will be evaluated as yes/no.
次要结局
- Incidence of postoperative hoarseness.(24 hours postoperatively)
- Intraoperative highest inspiratory pressure (Ppeak)(Throughout the duration of the surgical procedure (approx. 30-120 minutes))
- Frequency and severity of postoperative sore throat according to postoperative time.(Measured at 2, 6, and 24 hours post-extubation.)
- Frequency of Cough at Specific Time Points Postoperatively(Measured at 2, 6, and 24 hours post-extubation)
- Incidence of postoperative cough(24 hours postoperatively)
- Incidence of postoperative stridor(24 hours postoperatively)
- Frequency of Hoarseness at Specific Time Points Postoperatively(Measured at 2, 6, and 24 hours post-extubation)
- Frequency of Stridor at Specific Time Points Postoperatively(Measured at 2, 6, and 24 hours post-extubation)
- Intraoperative End-tidal carbon dioxide (EtCO2)(Throughout the duration of the surgical procedure (approx. 30-120 minutes))
- Intraoperative Leak minute ventilation (MVleak)(Throughout the duration of the surgical procedure (approx. 30-120 minutes))
- Intraoperative Tidal volume(Throughout the duration of the surgical procedure (approx. 30-120 minutes))
研究者
Muhammed Yonucu
Resident Physician
Ankara Etlik City Hospital