Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

Study Overview
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Brief Summary
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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).

Official Title
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Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy: The Oxy-FOB STUDY

Conditions
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Pneumonia, Acute Respiratory Failure, Lung Cancer, Fibrosis Lung, Interstitial Lung Disease

Intervention / Treatment
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* Diagnostic Test: Bronchoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Oxygen Therapy (SOT)<br>Patients receiving low oxygen flow administration through nasal prongs, oxygen mask with or without reservoir, and Venturi mask. | Diagnostic Test: Bronchoscopy<br>* 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).<br>|
| High Flow oxygen through Nasal Cannula (HFNC)<br>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<br>* 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).<br>|
| Continuous Positive Airway Pressure (CPAP)<br>application of positive end-expiratory pressure (PEEP) throughout the whole respiratory cycle by means of interfaces such as mask or helmet | Diagnostic Test: Bronchoscopy<br>* 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).<br>|
| Non-Invasive Ventilation (NIV)<br>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<br>* 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).<br>|
| Invasive Mechanical Ventilation (iMV)<br>application of a ventilatory assistance in controlled or partial assisted modalities through an endotracheal or tracheostomy tube | Diagnostic Test: Bronchoscopy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through the endoscopy completion, an average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through the endoscopy completion, an average of 30 minutes | 
| Lowest peripheral oxygen saturation | The lowest peripheral oxygen saturation recorded during the procedure | Through the endoscopy completion, an average of 30 minutes | 
| Lowest heart rate | The lowest heart rate recorded during the procedure | Through the endoscopy completion, an average of 30 minutes | 
| Highest heart rate | The highest heart rate recorded during the procedure | Through the endoscopy completion, an average of 30 minutes | 
| Lowest systolic blood pressure | The lowest systolic blood pressure recorded during the procedure | Through the endoscopy completion, an average of 30 minutes | 
| Highest systolic blood pressure | The highest systolic blood pressure recorded during the procedure | 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 | From the beginning to the end of the endoscopy procedure | 
| Desaturation events | Occurrence of peripheral oxygen saturation < 90% for at least 10 seconds | Through the endoscopy completion, an average of 30 minutes | 
| Severe desaturation events | Occurrence of peripheral oxygen saturation < 80% | Through the endoscopy completion, an average of 30 minutes | 
| Hypotensive events | Occurrence of systolic blood pressure <90 mmHg | Through the endoscopy completion, an average of 30 minutes | 
| Hypertensive events | Occurrence of systolic blood pressure >140 mmHg | 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) | 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 | At the end of the endoscopy completion, after an average of 30 minutes from study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchoscopy