Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

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

4 июля 2026 г. обновлено: Muhammed Yonucu, Ankara Etlik City Hospital

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

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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

60

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Muhammed Yonucu, MD, Resident in Anesthesiology
  • Номер телефона: +905535222961
  • Электронная почта: harrenhal61@gmail.com

Места учебы

  • Турция (Туркие)
    • Yenimahalle
      • Ankara, Yenimahalle, Турция (Туркие), 06010
        • Рекрутинг
        • Ankara Etlik City Hospital
        • Контакт:
          • Muhammed Yonucu, MD, Resident in Anesthesiology
          • Номер телефона: 05535222961
          • Электронная почта: harrenhal61@gmail.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • 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..

Exclusion Criteria:

  • 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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Тройной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: 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.
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.
Другие имена:
  • Manual cuff pressure estimation
  • Pilot balloon palpation
  • Subjective cuff inflation
  • Standard clinical cuff management
Экспериментальный: 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).
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).
Другие имена:
  • Invasive blood pressure monitoring set
  • Continuous cuff pressure monitoring

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Incidence of Postoperative Sore Throat
Временное ограничение: 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.
24 hours postoperatively

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Incidence of postoperative hoarseness.
Временное ограничение: 24 hours postoperatively

The frequency of hoarseness will be assessed and compared between groups within the first 24 hours after surgery.

Hoarseness will be defined as an abnormal change in the voice, such as the voice sounding breathy, muffled, strained, or a change in loudness or pitch.

It will be evaluated as yes/no.
24 hours postoperatively
Intraoperative highest inspiratory pressure (Ppeak)
Временное ограничение: Throughout the duration of the surgical procedure (approx. 30-120 minutes)
The highest inspiratory pressure (Ppeak) (mmHg) measured after intubation (T0), after pneumoperitoneum (T1), and every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te) will be recorded and compared between groups.
Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Frequency and severity of postoperative sore throat according to postoperative time.
Временное ограничение: Measured at 2, 6, and 24 hours post-extubation.
Assessment of the presence and severity of sore throat after extubation. Severity is scored using a 4-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Comparisons will be made between groups after the assessment.
Measured at 2, 6, and 24 hours post-extubation.
Frequency of Cough at Specific Time Points Postoperatively
Временное ограничение: Measured at 2, 6, and 24 hours post-extubation
Postoperative cough will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation. It will be evaluated as yes/no.
Measured at 2, 6, and 24 hours post-extubation
Incidence of postoperative cough
Временное ограничение: 24 hours postoperatively

The frequency of cough will be assessed and compared between groups within the first 24 hours after surgery.

It will be evaluated as yes/no.
24 hours postoperatively
Incidence of postoperative stridor
Временное ограничение: 24 hours postoperatively

The frequency of stridor will be assessed and compared between groups within the first 24 hours after surgery.

In a situation where the patient is pain-free (calm), airway secretions are completely cleared, and there is no anatomical/residual airway obstruction, a new, high-pitched inspiratory sound that occurs after extubation will be considered stridor.

It will be evaluated as yes/no.
24 hours postoperatively
Frequency of Hoarseness at Specific Time Points Postoperatively
Временное ограничение: Measured at 2, 6, and 24 hours post-extubation

Postoperative hoarseness will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation.

It will be evaluated as yes/no. Hoarseness will be defined as an abnormal change in the voice, such as the voice sounding breathy, muffled, strained, or a change in loudness or pitch.
Measured at 2, 6, and 24 hours post-extubation
Frequency of Stridor at Specific Time Points Postoperatively
Временное ограничение: Measured at 2, 6, and 24 hours post-extubation

Postoperative stridor will be assessed and compared between groups 2, 6, and 24 hours after discontinuation of intubation.

It will be evaluated as yes/no. In a situation where the patient is pain-free (calm), airway secretions are completely cleared, and there is no anatomical/residual airway obstruction, a new, high-pitched inspiratory sound that occurs after extubation will be considered stridor.
Measured at 2, 6, and 24 hours post-extubation
Intraoperative End-tidal carbon dioxide (EtCO2)
Временное ограничение: Throughout the duration of the surgical procedure (approx. 30-120 minutes)
End-tidal carbon dioxide (EtCO2) (mmHg) will be recorded and compared between groups after intubation (T0), after pneumoperitoneum (T1), every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te).
Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Intraoperative Leak minute ventilation (MVleak)
Временное ограничение: Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Leak minute ventilation (MVleak) (L/minute) values will be recorded and compared between groups after intubation (T0), after pneumoperitoneum (T1), every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te).
Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Intraoperative Tidal volume
Временное ограничение: Throughout the duration of the surgical procedure (approx. 30-120 minutes)
Tidal volume (ml) values will be recorded and compared between groups after intubation (T0), after pneumoperitoneum (T1), every 15 minutes (T1+15 min=T2, T2+15 min=T3), after abdominal desufflation (Td), and before extubation (Te).
Throughout the duration of the surgical procedure (approx. 30-120 minutes)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Ankara Etlik City Hospital

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

30 июня 2026 г.

Первичное завершение (Оцененный)

3 августа 2026 г.

Завершение исследования (Оцененный)

25 августа 2026 г.

Даты регистрации исследования

Первый отправленный

22 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

28 июня 2026 г.

Первый опубликованный (Действительный)

1 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

7 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

4 июля 2026 г.

Последняя проверка

1 июля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • AEŞH-EK-2026-037

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

The individual participant data collected during the study are considered confidential institutional data according to the study protocol and informed consent forms approved by the local ethics committee. The data will only be available to authorized regulatory bodies and the investigation team to ensure participant privacy and data security.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться