Clinical Trial

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

Recruiting
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Record status
This record was last updated December 30, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-01-03; most recent amendment 2024-12-24.
Status change: Not Yet Recruiting → Recruiting 2023-08-21
Trial Details
NCT Number NCT05681962
Lead Sponsor University Magna Graecia
Conditions Acute Respiratory Failure, Pneumonia, Lung Cancer, Fibrosis Lung, Interstitial Lung Disease
Enrollment 10,000 participants
Start Date 2023-02-15
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-01-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-30