Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

Recruiting

• Conditions: Fibrosis Lung; Interstitial Lung Disease; Lung Cancer; Acute Respiratory Failure; Pneumonia
• Interventions: Diagnostic Test: Bronchoscopy

• Registration Number: NCT05681962
• Lead Sponsor: University Magna Graecia

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-12
• Study Start: 2023-02-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Type of oxygenation strategy adopted	Through the endoscopy completion, an average of 30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Lowest heart rate	Through the endoscopy completion, an average of 30 minutes	The lowest heart rate recorded during the procedure
Duration of the procedure	From the beginning to the end of the endoscopy procedure	The time duration of the procedure in minutes, from the beginning to the end of the endoscopy procedure
Desaturation events	Through the endoscopy completion, an average of 30 minutes	Occurrence of peripheral oxygen saturation \< 90% for at least 10 seconds
Admission to ward or intensive care unit	At the end of the endoscopy completion, after an average of 30 minutes from study start	Need for admission to ward or intensive care unit after the endoscopy completion
Type of sedation strategy adopted	Through the endoscopy completion, an average of 30 minutes	The type of sedation strategy (topical anesthesia, midazolam, propofol, remifentanil, fentanyl, dexmedetomidine, neuromuscular blocking agents) adopted during the bronchoscopy will be recorded.
Lowest peripheral oxygen saturation	Through the endoscopy completion, an average of 30 minutes	The lowest peripheral oxygen saturation recorded during the procedure
Lowest systolic blood pressure	Through the endoscopy completion, an average of 30 minutes	The lowest systolic blood pressure recorded during the procedure
Highest heart rate	Through the endoscopy completion, an average of 30 minutes	The highest heart rate recorded during the procedure
Hypotensive events	Through the endoscopy completion, an average of 30 minutes	Occurrence of systolic blood pressure \<90 mmHg
Severe desaturation events	Through the endoscopy completion, an average of 30 minutes	Occurrence of peripheral oxygen saturation \< 80%
Highest systolic blood pressure	Through the endoscopy completion, an average of 30 minutes	The highest systolic blood pressure recorded during the procedure
Hypertensive events	Through the endoscopy completion, an average of 30 minutes	Occurrence of systolic blood pressure \>140 mmHg
Need for support escalation	Through the endoscopy completion, an average of 30 minutes	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)

Trial Locations

Locations (1)

AOU Mater Domini; 🇮🇹 Catanzaro, Italy