Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy
NCT ID: NCT05681962
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2023-02-15
2026-01-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard Oxygen Therapy (SOT)
Patients receiving low oxygen flow administration through nasal prongs, oxygen mask with or without reservoir, and Venturi mask.
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).
High Flow oxygen through Nasal Cannula (HFNC)
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%
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).
Continuous Positive Airway Pressure (CPAP)
application of positive end-expiratory pressure (PEEP) throughout the whole respiratory cycle by means of interfaces such as mask or helmet
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).
Non-Invasive Ventilation (NIV)
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
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).
Invasive Mechanical Ventilation (iMV)
application of a ventilatory assistance in controlled or partial assisted modalities through an endotracheal or tracheostomy tube
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Federico Longhini
Director of the Intensive Care and Anesthesia Department
Principal Investigators
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Federico Longhini, MD
Role: PRINCIPAL_INVESTIGATOR
Magna Graecia University
Locations
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AOU Mater Domini
Catanzaro, , Italy
Countries
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Central Contacts
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Facility Contacts
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Federico Longhini, MD
Role: primary
References
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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 bronchoscopy: the OxyFOB study protocol. BMJ Open. 2025 Sep 2;15(9):e104747. doi: 10.1136/bmjopen-2025-104747.
Other Identifiers
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OxyFOB study
Identifier Type: -
Identifier Source: org_study_id