AOU Mater Domini
Catanzaro, Italy
Location status: Recruiting
NCT Number: NCT05681962
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Catanzaro, Italy
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Through the endoscopy completion, an average of 30 minutes
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
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
The lowest peripheral oxygen saturation recorded during the procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
The lowest heart rate recorded during the procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
The highest heart rate recorded during the procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
The lowest systolic blood pressure recorded during the procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
The highest systolic blood pressure recorded during the procedure
Time frame: From the beginning to the end of the endoscopy procedure
The time duration of the procedure in minutes, from the beginning to the end of the endoscopy procedure
Time frame: Through the endoscopy completion, an average of 30 minutes
Occurrence of peripheral oxygen saturation < 90% for at least 10 seconds
Time frame: Through the endoscopy completion, an average of 30 minutes
Occurrence of peripheral oxygen saturation < 80%
Time frame: Through the endoscopy completion, an average of 30 minutes
Occurrence of systolic blood pressure <90 mmHg
Time frame: Through the endoscopy completion, an average of 30 minutes
Occurrence of systolic blood pressure >140 mmHg
Time frame: Through the endoscopy completion, an average of 30 minutes
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: At the end of the endoscopy completion, after an average of 30 minutes from study start
Need for admission to ward or intensive care unit after the endoscopy completion
Contact information is provided by the study sponsor or research team.
University Magna Graecia
Other
Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: the Oxy-FOB STUDY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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