Effect of Endotracheal Tube Cuff Pressure Management on Postoperative Sore Throat in Pediatric Laparoscopic Appendectomy

Официальное название

The Effect of Intraoperative Endotracheal Tube Cuff Pressure on Postoperative Sore Throat in Pediatric Patients Undergoing Laparoscopic Appendectomy: A Prospective Randomized Controlled Trial.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Pressure Transducer
  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).
• Процедура Traditional Palpation Method
  The endotracheal tube cuff pressure was adjusted by the anesthesiologist using the subjective manual palpation technique, where the pressure in the cuff was estimated by manually squeezing the pilot balloon. No external monitoring device was used in this group, reflecting the conventional clinical practice.

Первичные конечные точки

• Incidence of Postoperative Sore Throat [Срок оценки: 24 hours postoperatively]

Вторичные конечные точки (11)

• Incidence of postoperative hoarseness. [Срок оценки: 24 hours postoperatively]
• Intraoperative highest inspiratory pressure (Ppeak) [Срок оценки: Throughout the duration of the surgical procedure (approx. 30-120 minutes)]
• Frequency and severity of postoperative sore throat according to postoperative time. [Срок оценки: Measured at 2, 6, and 24 hours post-extubation.]
• Frequency of Cough at Specific Time Points Postoperatively [Срок оценки: Measured at 2, 6, and 24 hours post-extubation]
• Incidence of postoperative cough [Срок оценки: 24 hours postoperatively]
• Incidence of postoperative stridor [Срок оценки: 24 hours postoperatively]
• Frequency of Hoarseness at Specific Time Points Postoperatively [Срок оценки: Measured at 2, 6, and 24 hours post-extubation]
• Frequency of Stridor at Specific Time Points Postoperatively [Срок оценки: Measured at 2, 6, and 24 hours post-extubation]
• Intraoperative End-tidal carbon dioxide (EtCO2) [Срок оценки: Throughout the duration of the surgical procedure (approx. 30-120 minutes)]
• Intraoperative Leak minute ventilation (MVleak) [Срок оценки: Throughout the duration of the surgical procedure (approx. 30-120 minutes)]
• Intraoperative Tidal volume [Срок оценки: Throughout the duration of the surgical procedure (approx. 30-120 minutes)]

Критерии участия

Критерии включения

• 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..

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Ankara Etlik City Hospital — Ankara

Публикации

• Ban MG, Kim SY, Kim MS, Park WK, Kwon YI, Kim HJ. Accuracy of pilot balloon palpation for cuff pressure assessment in small versus large sized tubes: a prospective non-randomized observational study. Sci Rep. 2023 Apr 5;13(1):5580. doi: 10.1038/s41598-023-32704-3. PMID 37020098
• Ganason N, Sivanaser V, Liu CY, Maaya M, Ooi JSM. Post-operative Sore Throat: Comparing the Monitored Endotracheal Tube Cuff Pressure and Pilot Balloon Palpation Methods. Malays J Med Sci. 2019 Sep;26(5):132-138. doi: 10.21315/mjms2019.26.5.12. Epub 2019 Nov 4. PMID 31728125
• Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24. PMID 20736432
• Wang C, Yan X, Gao C, Liu S, Bao D, Zhang D, Jiang J, Wu A. Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: a randomized controlled trial. J Clin Monit Comput. 2024 Dec;38(6):1379-1386. doi: 10.1007/s10877-024-01173-y. Epub 2024 May 11. PMID 38733506

Идентификаторы

NCT: NCT07678086 · AEŞH-EK-2026-037

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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