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Сравнение влияния двух методов на отек гортани при раздувании эндотрахеальной манжетки

17 сентября 2026 г. обновлено: Mustafa Berkehan Nizamlıoğlu, Fatih Sultan Mehmet Training and Research Hospital

Сравнение традиционных и манометрических методов измерения при оценке периоперационного отека гортани с помощью УЗИ у пациентов, перенесших операцию по стабилизации поясничного отдела позвоночника

In this study, the investigators aimed to evaluate perioperative laryngeal edema in patients undergoing lumbar stabilization surgery in the pron position, which the investigators use in our routine anesthesia practice, by using conventional and manometry measurement methods and ultrasonography, which the investigators also use frequently in our routine, and to evaluate complications related to laryngeal edema in postoperative service follow-up.

Обзор исследования

Статус

Завершенный

Подробное описание

Lumbar spine surgery is commonly performed in the prone position. Although the prone position provides optimal surgical exposure, it may be associated with several physiological and position-related complications. Increased intra-abdominal and intrathoracic pressures may affect venous return and hemodynamics, while compression of the face, neck, and upper airway may contribute to facial and laryngeal edema. In addition, displacement, obstruction, or kinking of the endotracheal tube may occur after positioning.

Endotracheal tube cuff pressure represents another potential contributor to airway morbidity. The recommended cuff pressure is generally 25-30 cmH₂O. Excessive cuff pressure may impair tracheal mucosal perfusion and contribute to mucosal injury and postoperative airway symptoms. In conventional clinical practice, cuff inflation is often performed by manual palpation of the pilot balloon, whereas cuff manometry allows objective measurement and adjustment of cuff pressure.

Ultrasonographic measurement of laryngeal air column width (ACW) provides a non-invasive method for assessing peri-extubation changes in the upper airway. In this study, ACW is measured after tracheal intubation and again before extubation, and the pre-extubation/post-intubation ACW ratio is used to assess perioperative changes suggestive of laryngeal edema.

This prospective observational study evaluates peri-extubation laryngeal edema in adult patients undergoing elective lumbar stabilization surgery in the prone position at Fatih Sultan Mehmet Training and Research Hospital. Participants are categorized according to the endotracheal tube cuff inflation technique used as part of routine anesthetic care: conventional pilot balloon palpation (Conventional group) or manometer-guided cuff inflation (Manometer group). No study-specific random allocation is performed, and the cuff inflation technique is determined as part of routine anesthetic practice rather than by the research protocol.

After standard monitoring and induction of general anesthesia, patients are intubated by direct laryngoscopy using an appropriately sized reinforced orotracheal tube. In the Conventional group, the endotracheal tube cuff is inflated manually according to the attending anesthesiologist's routine clinical practice, after which cuff pressure is measured using a cuff manometer and recorded. In the Manometer group, cuff pressure is adjusted to 25-30 cmH₂O using a cuff manometer. Thereafter, cuff pressure is measured and recorded at 30-minute intervals throughout the operation in both groups. In the Conventional group, cuff pressure is measured and recorded at these intervals without protocol-driven adjustment, whereas in the Manometer group, cuff pressure is readjusted to 25-30 cmH₂O when necessary.

Following intubation, laryngeal ACW is measured ultrasonographically in the transverse plane at the level of the cricothyroid membrane using a linear transducer. Patients are subsequently positioned prone with particular attention to avoiding pressure on the eyes, face, and neck. Mechanical ventilation is provided using volume-controlled ventilation with a tidal volume of 8 mL/kg, positive end-expiratory pressure of 5 cmH₂O, and a respiratory rate adjusted to maintain end-tidal carbon dioxide between 35 and 40 mmHg. General anesthesia is maintained with desflurane and remifentanil, with anesthetic agents titrated according to hemodynamic parameters and Patient State Index values. Routine hemodynamic and respiratory parameters are monitored and recorded throughout the procedure.

At the end of surgery, patients are returned to the supine position. Before extubation, laryngeal ACW is measured again using the same ultrasonographic technique. For ACW measurements, oral secretions are aspirated and the endotracheal tube cuff is deflated. After measurement, the cuff is reinflated to the appropriate pressure using a cuff manometer. The ACW ratio is calculated as the pre-extubation ACW divided by the post-intubation ACW.

After recovery from neuromuscular blockade and fulfillment of standard extubation criteria, patients are extubated and transferred to the post-anesthesia care unit. Postoperative airway-related symptoms, including cough, dyspnea, dysphagia, dysphonia, sore throat, and facial edema, are assessed during postoperative follow-up at 4, 8, and 24 hours after surgery.

Тип исследования

Наблюдательный

Регистрация (Действительный)

62

Контакты и местонахождение

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

Места учебы

    • Atasehir
      • Istanbul, Atasehir, Турция (Туркие), 34752
        • Fatih Sultan Mehmet Training and Research Hospital

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

От 18 лет до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

Adult patients aged 18-65 years with ASA physical status I-III undergoing elective lumbar stabilization surgery under general anesthesia in the prone position at Fatih Sultan Mehmet Training and Research Hospital. Eligible patients were prospectively enrolled according to the predefined inclusion and exclusion criteria. Participants were categorized according to the endotracheal tube cuff management technique used as part of routine anesthetic care (conventional pilot balloon palpation or manometer-guided cuff management); no study-specific random allocation was performed.

Описание

Inclusion Criteria:

  • Patients who will undergo lumbar spinal surgery under general anesthesia under elective conditions
  • Patients aged 18-65 years, included in the ASA I-III group
  • Patients whose consent has been obtained

Exclusion Criteria:

  • Patients under 18 years of age, over 65 years of age, included in the ASA IV-V group
  • Patients with a history of surgery in the oral cavity, including direct laryngoscopy and biopsy, microlaryngoscopic surgery, tonsillectomy, adenoidectomy, soft palate, oropharynx, hypopharynx, larynx and trachea,
  • Patients with a history of allergies, asthma, reflux, upper respiratory viral or fungal infections and cancer surgeries,
  • Patients receiving radiotherapy to the neck who had multiple intubation attempts in the previous year,
  • Patients undergoing emergency surgery,
  • Patients with advanced cardiac, renal, pulmonary and hepatic failure,
  • Patients who did not give consent to participate in the study.

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

  • Наблюдательные модели: COHORT
  • Временные перспективы: PROSPECTIVE

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
Conventional

The endotracheal tube cuff was manually inflated according to the attending anesthesiologist's routine clinical practice. The initial cuff pressure was subsequently measured using a cuff manometer and recorded. During surgery, cuff pressure was measured and recorded at 30-minute intervals without protocol-driven adjustment.

The endotracheal tube cuff was manually inflated according to the attending anesthesiologist's routine clinical practice. The initial cuff pressure was subsequently measured using a cuff manometer and recorded. During surgery, cuff pressure was measured and recorded at 30-minute intervals without protocol-driven adjustment. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol.

Manometer

The endotracheal tube cuff pressure was initially adjusted to 25-30 cmH₂O using a cuff manometer. During surgery, cuff pressure was measured and recorded at 30-minute intervals and was readjusted to 25-30 cmH₂O when necessary. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol.

The endotracheal tube cuff pressure was initially adjusted to 25-30 cmH₂O using a cuff manometer. During surgery, cuff pressure was measured and recorded at 30-minute intervals and was readjusted to 25-30 cmH₂O when necessary. This cuff management approach was part of routine anesthetic care and was not assigned by the study protocol.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Measurement of airway column width
Временное ограничение: through study completion, an average of 6 months

Measurement of the effect of conventional and manometry methods on air column width by ultrasonography. With ultrasonography, laryngeal edema development can be observed in patients by measuring the air column width after intubation and before extubation in the transverse axis with a linear probe over the patient's cricothyroid membrane

through study completion, an average of 6 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Detection of complications due to postoperative laryngeal edema
Временное ограничение: It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours

Detection of cough, dyspnea, dysphagia, dysphonia, dysphonia, facial edema that may occur after surgery for laryngeal edema.

It will be evaluated at PACU 5th minute and postoperative 4, 8, 24th hours

Соавторы и исследователи

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

Следователи

  • Директор по исследованиям: Arzu Yildirim Ar, As Prof, Fatih Sultan Mehmet Training and Research 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 (Действительный)

1 февраля 2025 г.

Первичное завершение (Действительный)

30 июня 2025 г.

Завершение исследования (Действительный)

10 июля 2025 г.

Даты регистрации исследования

Первый отправленный

28 декабря 2024 г.

Впервые представлено, что соответствует критериям контроля качества

7 января 2025 г.

Первый опубликованный (Действительный)

13 января 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

22 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

17 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

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. .

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