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Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05681962
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Magna Graecia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Federico Longhini, MD
Principal Investigator Affiliation	Magna Graecia University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Acute Respiratory Failure, Pneumonia, Lung Cancer, Fibrosis Lung, Interstitial Lung Disease

Arms & Interventions

Arms

: Standard Oxygen Therapy (SOT)

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

: High Flow oxygen through Nasal Cannula (HFNC)

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)

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

: Non-Invasive Ventilation (NIV)

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

: Invasive Mechanical Ventilation (iMV)

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

Interventions

Diagnostic Test: - Bronchoscopy

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).

Contact a Trial Team

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