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Набор скоро начнётся NCT07753278

Fresh Gas Flow and Lung Ultrasonography in Laparoscopic Cholecystectomy

Без фазы С лечением Postoperative Atelectasis Pulmonary Atelectasis

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: Low Fresh Gas Flow (0.5 L/min), High Fresh Gas Flow (4 L/min).
Кому может быть актуально
Состояния в реестре: Postoperative Atelectasis, Pulmonary Atelectasis. 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 →
Официальное название

Evaluation of the Effects of Fresh Gas Flow Differences on the Lungs Using Ultrasonography in Laparoscopic Cholecystectomy Surgeries

Обзор

This prospective randomized clinical trial aims to evaluate the effects of different fresh gas flow rates on postoperative pulmonary aeration using lung ultrasonography in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomly assigned to receive either low-flow anesthesia (0.5 L/min) or high-flow anesthesia (4 L/min) during maintenance of general anesthesia. The primary objective is to compare postoperative lung ultrasound scores and the incidence of atelectasis between the two groups.

Подробное описание

Pulmonary atelectasis is one of the most common postoperative pulmonary complications following general anesthesia. Fresh gas flow is an important component of inhalational anesthesia and may influence airway humidity, gas exchange, respiratory mechanics, and pulmonary physiology. Although low-flow anesthesia has recognized economic, environmental, and physiological advantages, the effect of different fresh gas flow rates on postoperative lung aeration has not been adequately investigated.

This prospective, randomized, parallel-group clinical trial will be conducted at Adıyaman University Training and Research Hospital. Adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be randomly allocated to either a low-flow group (0.5 L/min) or a high-flow group (4 L/min) after an initial fresh gas flow of 4 L/min for 8 minutes following endotracheal intubation. Standardized anesthesia management will be applied to all participants.

Postoperative lung ultrasonography will be performed 30 minutes after extubation in the post-anesthesia care unit. Lung Ultrasound Score (LUS) and the incidence of postoperative atelectasis will be compared between the study groups. The findings are expected to provide evidence regarding the effects of different fresh gas flow strategies on postoperative pulmonary outcomes and may contribute to optimizing intraoperative anesthesia management.

Вмешательства

  • Процедура Low Fresh Gas Flow (0.5 L/min)
    General anesthesia will be maintained using a fresh gas flow rate of 0.5 L/min after an initial fresh gas flow of 4 L/min for 8 minutes following endotracheal intubation.
  • Процедура High Fresh Gas Flow (4 L/min)
    General anesthesia will be maintained using a fresh gas flow rate of 4 L/min after an initial fresh gas flow of 4 L/min for 8 minutes following endotracheal intubation.

Первичные конечные точки

  • Postoperative Lung Ultrasound Score [Срок оценки: 30 minutes after extubation]
Вторичные конечные точки (5)
  • Incidence of postoperative atelectasis [Срок оценки: 30 minutes after extubation]
  • Peripheral oxygen saturation (SpO₂) [Срок оценки: During surgery]
  • Mean arterial pressure [Срок оценки: During surgery]
  • Heart rate [Срок оценки: During surgery]
  • Peak airway pressure [Срок оценки: Throughout the intraoperative period]

Критерии участия

Критерии включения

  • Adults aged 18 years or older.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
  • Able and willing to provide written informed consent.

Критерии исключения

  • Refusal to participate in the study.
  • History of chronic respiratory disease, including severe asthma, chronic obstructive pulmonary disease (COPD), or bronchiolitis.
  • History of alcohol or substance abuse.
  • Intraoperative airway or respiratory complications during endotracheal intubation or surgery.
  • Life-threatening postoperative complications.
  • Patients with ASA physical status III or higher.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Adıyaman Training and Research Hospital — Adıyaman

Идентификаторы

NCT: NCT07753278 · AH-AR-MD-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗