Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

University Magna Graecia

Status: Enrolling

Conditions: Fibrosis Lung; Lung Cancer; Pneumonia; Acute Respiratory Failure; Interstitial Lung Disease

Treatments: Diagnostic Test: Bronchoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05681962

OxyFOB study

Details and patient eligibility

About

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).

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10,000 participants in 5 patient groups

Standard Oxygen Therapy (SOT)

Description:

Patients receiving low oxygen flow administration through nasal prongs, oxygen mask with or without reservoir, and Venturi mask.

Treatment:

Diagnostic Test: Bronchoscopy

High Flow oxygen through Nasal Cannula (HFNC)

Description:

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%

Treatment:

Diagnostic Test: Bronchoscopy

Continuous Positive Airway Pressure (CPAP)

Description:

application of positive end-expiratory pressure (PEEP) throughout the whole respiratory cycle by means of interfaces such as mask or helmet

Treatment:

Diagnostic Test: Bronchoscopy

Non-Invasive Ventilation (NIV)

Description:

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

Treatment:

Diagnostic Test: Bronchoscopy

Invasive Mechanical Ventilation (iMV)

Description:

application of a ventilatory assistance in controlled or partial assisted modalities through an endotracheal or tracheostomy tube

Treatment:

Diagnostic Test: Bronchoscopy