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Идёт набор NCT06511583

FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department

— Наблюдательное Aspiration Pneumonia Bronchoscopy

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: Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department, Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department.
Кому может быть актуально
Состояния в реестре: Aspiration Pneumonia, Bronchoscopy. Базовые параметры: от 18 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
Италия
Следующий шаг
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Обзор

Non-Profit Prospective Observational Pilot Study The study will have an overall duration of 3 years, with patient enrollment starting after ethical committee approval. In this study, all patients with a diagnosis of aspiration pneumonia who require aspiration of secretions or ingesta in the Emergency Department will be considered. A registry will be created with the patients\' data, noting the type of procedure performed: laryngotracheal aspiration with a probe or with fibrobronchoscopy. This observational registry pilot study aims to evaluate the utility and adverse events related to the use of aspiration via videobronchoscopy performed in the Emergency Department and to compare the clinical outcomes of patients undergoing bronchoscopy with those treated only with blind laryngotracheal aspiration using a probe.

Вмешательства

  • Процедура Laryngotracheal Aspiration Procedure Using a Probe in the Emergency Department
    For laryngotracheal aspiration using a blind probe, the patient will be positioned in a seated or semi-seated position; if this is not possible, the aspiration will be performed in a supine position. A soft, sterile catheter connected to the suction apparatus will be inserted into one nostril while keeping the patient\'s head tilted back. When the tip of the catheter reaches the back of the pharynx, the patient will need to breathe to facilitate the insertion and allow the catheter to advanc
  • Процедура Aspiration Procedure Using Fibrobronchoscopy in the Emergency Department
    Equipment Setup: A sterile bronchoscope will be connected to the suction apparatus. Procedure: The bronchoscope will be gently inserted through the patient\'s nostril or mouth, advancing carefully through the pharynx and larynx into the trachea and bronchi. The physician will visually inspect the airways through the bronchoscope. Using the bronchoscope's suction channel, secretions will be aspirated from the trachea and bronchi. Suctioning will be performed intermittently to avoid hypox

Первичные конечные точки

  • Length of hospital stay in days [Срок оценки: up to 3 months]
  • Mortality rate within 30 days from the time of admission to the Emergency Department [Срок оценки: 30 days from admission to the ed]
Вторичные конечные точки (4)
  • Respiratory parameters before and after the procedure [Срок оценки: on the admission and 30 minutes after the procedure]
  • Rate of patient treated with Non invase ventilation and with orotracheal intubation [Срок оценки: on the admission and 30 minutes after the procedure]
  • Rate of admission in Intensive care unit and High dependency unit [Срок оценки: immediately after the procedure]
  • Procedure-related complications [Срок оценки: perioperatively/periprocedurally]

Критерии участия

Критерии включения

All adult patients who access the Emergency Department with a diagnosis of aspiration pneumonia and for whom the referring physician determines the need for aspiration of secretions or ingesta. Patients must have at least one of the following criteria

  • Radiological evidence of pneumonia (Chest X-ray/CT scan/Chest ultrasound)
  • Clinical diagnosis of aspiration pneumonia
  • Presence of secretions in the upper airways
  • Respiratory distress in a dysphagic patient
  • Need for oxygen therapy or need to increase FiO2 in patients already on home oxygen therapy

Критерии исключения

  • Lack of consent
  • Age \< 18 years
  • Pregnancy
  • Hemorrhagic diathesis
  • Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block)
  • Severe airway obstruction

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Италия · 1 центр
  • AOU Careggi — Florence

Публикации

  • Pelagatti L, Montalbetti A, Viviani G, Ferretti A, Trigiani M, Corbetta L, Tomassetti S, Vanni S, Nazerian P. Fibrobronchoscopy versus laryngotracheal aspiration for bronchial toileting in patients with aspiration pneumonia in the emergency department. FBS-ASaP prospective case-control study. Intern Emerg Med. 2026 Apr;21(3):1077-1086. doi: 10.1007/s11739-025-04002-5. Epub 2025 Jun 8. PMID 40483618

Идентификаторы

NCT: NCT06511583 · CEAVC 22814

Первоисточники (государственные реестры)

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