Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

Trial Title: Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

NCT ID: NCT05681962

Condition: Acute Respiratory Failure
Pneumonia
Lung Cancer
Fibrosis Lung
Interstitial Lung Disease

Conditions: Official terms:
Lung Diseases
Respiratory Insufficiency
Lung Diseases, Interstitial
Pulmonary Fibrosis

Conditions: Keywords:
Bronchoscopy

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Bronchoscopy
Description: 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).
Arm group label: Continuous Positive Airway Pressure (CPAP)
Arm group label: High Flow oxygen through Nasal Cannula (HFNC)
Arm group label: Invasive Mechanical Ventilation (iMV)
Arm group label: Non-Invasive Ventilation (NIV)
Arm group label: Standard Oxygen Therapy (SOT)

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).

Criteria for eligibility:

Study pop:
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)

Sampling method: Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: AOU Mater Domini

Address:
City: Catanzaro
Country: Italy

Status: Recruiting

Contact:
Last name: Federico Longhini, MD

Phone: +3934753959697
Email: longhini.federico@gmail.com

Start date: February 15, 2023

Completion date: April 30, 2024

Lead sponsor:
Agency: University Magna Graecia
Agency class: Other

Source: University Magna Graecia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05681962