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Идёт набор NCT07430124

Flow-Controlled Versus Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy

Без фазы С лечением Airway Stenosis Upper Airway Obstruction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: FCV Group, VCV Group.
Кому может быть актуально
Состояния в реестре: Airway Stenosis, Upper Airway Obstruction. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparison of Flow-Controlled and Volume-Controlled Ventilation During Balloon Dilatation Under Direct Laryngoscopy: A Prospective Randomized Trial

Обзор

This prospective trial aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on airway pressures and oxygenation in adult patients undergoing balloon dilatation under direct laryngoscopy. Airway procedures performed under general anesthesia are associated with unique respiratory mechanics and limited ventilation conditions, making the choice of an optimal ventilation strategy particularly important. Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be allocated to receive either FCV or VCV during surgery. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas values will be recorded at predefined intraoperative time points. The primary outcome is the PaO₂ measured 20 minutes under an FiO₂ of 0.8-1.0 after starting the ventilation under general anesthesia, reflecting early intraoperative oxygenation under stable conditions. By providing comparative data on respiratory mechanics and oxygenation, this study aims to contribute to the identification of lung-protective ventilation strategies in patients undergoing balloon dilatation under direct laryngoscopy.

Вмешательства

  • Процедура FCV Group
    Patients allocated to the FCV group will receive mechanical ventilation using a flow-controlled ventilation mode throughout the surgical procedure performed under general anesthesia. Ventilation will be managed according to routine clinical practice, with standardized anesthetic induction and monitoring. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas values will be recorded at predefined intraoperative time points, including after starting the ventilation
  • Процедура VCV Group
    Patients allocated to the VCV group will receive mechanical ventilation using a conventional volume-controlled ventilation mode throughout the surgical procedure under general anesthesia. Anesthetic management and monitoring will follow standard clinical protocols identical to those applied in the FCV group. Ventilatory parameters, airway pressures, pulmonary compliance, and arterial blood gas measurements will be recorded at the same predefined intraoperative time points, including after starti

Первичные конечные точки

  • The PaO₂ measured 20 minutes after intubation. [Срок оценки: 20 minutes after intubation in the intraoperative period]
Вторичные конечные точки (3)
  • The PaO₂ measured during perioperative period [Срок оценки: At the initiation of mechanical ventilation following intubation and at the first postoperative hour after extubation]
  • Peak airway pressure (Ppeak) values during perioperative period. [Срок оценки: At the initiation of mechanical ventilation following intubation and 20 minutes after intubation]
  • Plateau airway pressure (Pplateau) values during perioperative period [Срок оценки: At the initiation of mechanical ventilation following intubation and 20 minutes after intubation]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • ASA physical status I-III

Критерии исключения

  • Age < 18 years or > 65 years
  • Known or previously diagnosed pulmonary disease
  • Patients with severe preoperative pulmonary function impairment (e.g., FEV₁ < 50% predicted, severe restrictive or obstructive pathology)
  • Patients with markedly altered lung anatomy or function due to prior major thoracic surgery
  • Patients who were dependent on supplemental oxygen therapy in the preoperative period
  • ASA physical status IV or higher
  • Refusal or inability to provide informed consent

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
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara Etlik City Hospital — Ankara

Идентификаторы

NCT: NCT07430124 · AEŞH-EK-2026-012

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗