NCT05681962

Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: University Magna Graecia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Respiratory Failure
• Pneumonia
• Lung Cancer
• Fibrosis Lung
• Interstitial Lung Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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).

Timeline

• Start date: 2023-02-15
• Primary completion: 2025-12-31
• Completion: 2026-01-31
• First posted: 2023-01-12
• Last updated: 2024-12-30

Locations

1 site across 1 country: Italy