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Идёт набор NCT05681962

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

— Наблюдательное Acute Respiratory Failure Pneumonia Lung Cancer Fibrosis Lung

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: Bronchoscopy.
Кому может быть актуально
Состояния в реестре: Acute Respiratory Failure, Pneumonia, Lung Cancer, Fibrosis Lung. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: the Oxy-FOB STUDY

Обзор

The current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy is very heterogeneous among studies published in the literature; in addition, clear outcomes advantages of one strategy over another currently lack. The goal of this observational study is to describe the current practice of oxygenation and/or ventilation supports in patients undergoing Fiberoptic Bronchoscopy (FOB), stratified by baseline respiratory condition, co-morbidities, type of procedure and hospital settings. Investigators will enroll all adult patients undergoing any fiberoptic bronchoscopy in any clinical settings (from outpatients to critically ill patients). No specific exclusion criteria are indicated for enrollment in this study. Investigators will record the following data: * Patient's baseline data. * Type of FOB procedure: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (BAS), bronchoalveolar lavage (BAL), brushing for cytology, biopsy, endobronchial ultrasound (EBUS). The type and size of bronchoscope (with or without an internal/external camera) and the time of the procedure will be also recorded. * Type of supportive strategy: no support, Standard Oxygen Therapy, High Flow Nasal Cannula, Continuous Positive Airway Pressure and or non invasive ventilation trough mask or helmet, invasive mechanical ventilation. * Sedation * Intra-procedural vital parameters * Occurrence of adverse events: desaturation (i.e. SpO2\< 90% for at least 10 seconds), severe desaturation (i.e. SpO2\< 80%), need for procedure interruption, hypotensive (systolic blood pressure \<90 mmHg) or hypertensive (systolic blood pressure \>140 mmHg) events, new onset of cardiac arrhythmias (specify the rhythm) or myocardial ischemia or electrocardiographic ST-alterations, neurological events (i.e. severe sensorium depression, psychomotor agitation). * Post-procedural vital parameters (15 minutes after the procedure). * Clinical outcomes: need for support escalation, need for admission to ward (for outpatient) or ICU (for outpatients and ward-admitted patient).

Вмешательства

  • Диагностический тест Bronchoscopy
    Patients will undergo to the bronchial endoscopy procedure required for their clinical condition: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (BAS), bronchoalveolar lavage (BAL), brushing for cytology, biopsy, endobronchial ultrasound (EBUS).

Первичные конечные точки

  • Type of oxygenation strategy adopted [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
Вторичные конечные точки (12)
  • Type of sedation strategy adopted [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Lowest peripheral oxygen saturation [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Lowest heart rate [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Highest heart rate [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Lowest systolic blood pressure [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Highest systolic blood pressure [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Duration of the procedure [Срок оценки: From the beginning to the end of the endoscopy procedure]
  • Desaturation events [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Severe desaturation events [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Hypotensive events [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Hypertensive events [Срок оценки: Through the endoscopy completion, an average of 30 minutes]
  • Need for support escalation [Срок оценки: Through the endoscopy completion, an average of 30 minutes]

Критерии участия

Критерии включения

  • Need for any procedure with flexible FOB
  • Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)

Критерии исключения

  • None

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • AOU Mater Domini — Catanzaro

Публикации

  • Longhini F, Crimi C, Noto A, Pelaia C, Karakurt Z, Skoczynski S, Boleo-Tome JP, Winck JC, Esquinas AM, Melhorn J, Corneci D, Pobeha P, Bosco V, Garofalo E, Bruni A, Cammarota G, Todorova V, Puci MV, Sotgiu G, Kostikas K, Maggiore SM, De Robertis E, Ergan B, Landoni G, Simonte R, Nava S, Navalesi P, Scala R; OxyFOB study group. Practice of oxygenation and respiratory support during fibreoptic bronc PMID 40897500

Идентификаторы

NCT: NCT05681962 · OxyFOB study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗