Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bronchoscopy.
- Who it may be relevant to
- Registry conditions: Acute Respiratory Failure, Pneumonia, Lung Cancer, Fibrosis Lung. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: the Oxy-FOB STUDY
Overview
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).
Interventions
- 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).
Primary outcome measures
- Type of oxygenation strategy adopted [Time frame: Through the endoscopy completion, an average of 30 minutes]
Secondary outcome measures (12)
- Type of sedation strategy adopted [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Lowest peripheral oxygen saturation [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Lowest heart rate [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Highest heart rate [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Lowest systolic blood pressure [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Highest systolic blood pressure [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Duration of the procedure [Time frame: From the beginning to the end of the endoscopy procedure]
- Desaturation events [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Severe desaturation events [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Hypotensive events [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Hypertensive events [Time frame: Through the endoscopy completion, an average of 30 minutes]
- Need for support escalation [Time frame: Through the endoscopy completion, an average of 30 minutes]
Eligibility criteria
Inclusion criteria
- Need for any procedure with flexible FOB
- Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- AOU Mater Domini — Catanzaro
Publications
- 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 bronc PMID 40897500
Identifiers
NCT: NCT05681962 · OxyFOB study