An observational study in Acute Respiratory Failure, Pneumonia and Lung Cancer, sponsored by University Magna Graecia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by University Magna Graecia · Observational
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:
We will include all adult patients requiring a flexible bronchoscopy for diagnostic or procedural reasons from all possible settings (from outpatients in dedicated ambulatories to patients admitted in any hospital ward or Intensive Care Unit)
Exclusion Criteria:
Patients receiving low oxygen flow administration through nasal prongs, oxygen mask with or without reservoir, and Venturi mask.
Diagnostic Test: Bronchoscopy
Administration of high flows (up to 60 L/min) of air/oxygen admixtures, heated (at temperatures ranging from 31 to 37°C) and fully humidified (up to 44 mg H2O/L), providing an inspired oxygen fraction ranging from 21 to 100%
Diagnostic Test: Bronchoscopy
application of positive end-expiratory pressure (PEEP) throughout the whole respiratory cycle by means of interfaces such as mask or helmet
Diagnostic Test: Bronchoscopy
application of a PEEP by means of a mask or helmet, with an inspiratory pressure support triggered by the patient and delivered by a ventilator and through interfaces such as mask or helmet
Diagnostic Test: Bronchoscopy
application of a ventilatory assistance in controlled or partial assisted modalities through an endotracheal or tracheostomy tube
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).
Type of oxygenation strategy adopted
The type of oxygenation strategy (standard oxygen therapy, high flow nasal cannula, continuous positive airway pressure, non invasive ventilation or invasive mechanical ventilation) adopted during the bronchoscopy will be recorded.
Time frame: Through the endoscopy completion, an average of 30 minutes
Type of sedation strategy adopted
The type of sedation strategy (topical anesthesia, midazolam, propofol, remifentanil, fentanyl, dexmedetomidine, neuromuscular blocking agents) adopted during the bronchoscopy will be recorded.
Time frame: Through the endoscopy completion, an average of 30 minutes
Lowest peripheral oxygen saturation
The lowest peripheral oxygen saturation recorded during the procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
Lowest heart rate
The lowest heart rate recorded during the procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
Highest heart rate
The highest heart rate recorded during the procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
Lowest systolic blood pressure
The lowest systolic blood pressure recorded during the procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
Highest systolic blood pressure
The highest systolic blood pressure recorded during the procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
Duration of the procedure
The time duration of the procedure in minutes, from the beginning to the end of the endoscopy procedure
Time frame: From the beginning to the end of the endoscopy procedure
Desaturation events
Occurrence of peripheral oxygen saturation \< 90% for at least 10 seconds
Time frame: Through the endoscopy completion, an average of 30 minutes
Severe desaturation events
Occurrence of peripheral oxygen saturation \< 80%
Time frame: Through the endoscopy completion, an average of 30 minutes
Hypotensive events
Occurrence of systolic blood pressure \<90 mmHg
Time frame: Through the endoscopy completion, an average of 30 minutes
Hypertensive events
Occurrence of systolic blood pressure \>140 mmHg
Time frame: Through the endoscopy completion, an average of 30 minutes
Need for support escalation
Need to escalate the oxygenation/ventilation support from from standard oxygen therapy (lowest support) to High Flow Nasal Cannula, Continuous Positive Airway Pressure, Non Invasive Ventilation or invasive Mechanical Ventilation (highest grade of support)
Time frame: Through the endoscopy completion, an average of 30 minutes
Admission to ward or intensive care unit
Need for admission to ward or intensive care unit after the endoscopy completion
Time frame: At the end of the endoscopy completion, after an average of 30 minutes from study start
Plan to share: Yes — Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
Supporting information: Study protocol, Csr, Analytic code
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University Magna Graecia