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Идёт набор NCT07430111

Flow-Controlled Versus Volume-Controlled Ventilation in Bariatric Surgery

Без фазы С лечением Obesity Bariatric Surgery Mechanical Ventilation

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: Obesity, Bariatric Surgery, Mechanical Ventilation. 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
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Официальное название

Comparison of Flow-Controlled and Volume-Controlled Ventilation During Bariatric Surgery: A Prospective Randomized Trial

Обзор

This prospective trial aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on intraoperative airway pressures and oxygenation in bariatric surgery under general anesthesia. Obesity is associated with altered respiratory mechanics, reduced functional residual capacity, and increased airway pressures, making the selection of an optimal ventilation strategy particularly important in this patient population. Adult patients aged 18-65 years with a body mass index ≥30 kg/m² and American Society of Anesthesiologists (ASA) physical status II-III will be allocated to receive either FCV or VCV as part of routine intraoperative mechanical ventilation. Ventilatory parameters, including peak and plateau airway pressures, pulmonary compliance, will be recorded at predefined intraoperative time points. The primary endpoint of the study is the PaO₂ value measured at the 20th minute under an FiO₂ of 0.8-1.0. By providing comparative data on respiratory mechanics and oxygenation, this study aims to contribute to the identification of lung-protective ventilation strategies and to optimize intraoperative ventilatory management in bariatric surgery.

Вмешательства

  • Процедура FCV Group
    Patients allocated to the FCV group will receive intraoperative mechanical ventilation using a flow-controlled ventilation mode during surgery under general anesthesia. Patients will be started on ventilation after intubation with 50% oxygen, driving pressure 12, PEEP 5, and a 1:1 inspiration/expiratory ratio.
  • Процедура VCV Group
    Patients allocated to the VCV group will receive intraoperative mechanical ventilation using a conventional volume-controlled ventilation mode throughout surgery under general anesthesia. Patients will be started on ventilation after intubation with 50% oxygen, 7 ml/ideal body weight tidal volume, PEEP 5, 12 breaths per minute frequency, and a 1:2 inspiration/expiration ratio.

Первичные конечные точки

  • The PaO₂ value 20 minutes after insufflation. [Срок оценки: At 20 minutes after insufflation in the intraoperative period.]
Вторичные конечные точки (3)
  • The PaO₂ value during perioperative period [Срок оценки: At the beginning of the insufflation, 60 minutes after insufflation, before extubation, 1 hour after extubation.]
  • Peak airway pressure (Ppeak) values during perioperative period. [Срок оценки: At the beginning of the insufflation, 20 minutes after insufflation, 60 minutes after insufflation, before extubation, 1 hour after extubation.]
  • Plateau airway pressure (Pplateau) values during perioperative period [Срок оценки: At the beginning of the insufflation, 20 minutes after insufflation, 60 minutes after insufflation, before extubation, 1 hour after extubation.]

Критерии участия

Критерии включения

  • Age between 18 and 65 years
  • Body mass index (BMI) ≥ 30 kg/m²
  • ASA physical status II-III

Критерии исключения

  • ASA physical status I or IV and above
  • 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
  • Refusal to participate in the study or inability to comply with study procedures

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: NCT07430111 · AEŞH-EK-2026-011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗