Clinical trial NCT05681962: Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy
Official title: Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: the Oxy-FOB STUDY
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Failure
Pneumonia
Lung Cancer
Fibrosis Lung
Interstitial Lung Disease
Keywords: Bronchoscopy
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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)

Brief 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).


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

Primary outcomes:
measure: Type of oxygenation strategy adopted
timeFrame: Through the endoscopy completion, an average of 30 minutes
Secondary outcomes:
measure: Type of sedation strategy adopted
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Lowest peripheral oxygen saturation
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Lowest heart rate
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Highest heart rate
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Lowest systolic blood pressure
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Highest systolic blood pressure
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Duration of the procedure
timeFrame: From the beginning to the end of the endoscopy procedure
measure: Desaturation events
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Severe desaturation events
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Hypotensive events
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Hypertensive events
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Need for support escalation
timeFrame: Through the endoscopy completion, an average of 30 minutes
measure: Admission to ward or intensive care unit
timeFrame: At the end of the endoscopy completion, after an average of 30 minutes from study start
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AOU Mater Domini
Study officials:
affiliation: Magna Graecia University
name: Federico Longhini, MD
role: PRINCIPAL_INVESTIGATOR
References: