Practice of Oxygenation and Respiratory Support During Fiberoptic Bronchoscopy

NCT05681962 | Recruiting DMC

• 1 other identifier: OxyFOB study
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Type of sedation strategy adopted

  Through the endoscopy completion, an average of 30 minutes

• Lowest peripheral oxygen saturation

  Through the endoscopy completion, an average of 30 minutes

• Lowest heart rate

  Through the endoscopy completion, an average of 30 minutes

• Highest heart rate

  Through the endoscopy completion, an average of 30 minutes

• Lowest systolic blood pressure

  Through the endoscopy completion, an average of 30 minutes

Study Arms (5)

Standard Oxygen Therapy (SOT)

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

Diagnostic Test: Bronchoscopy

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%

Diagnostic Test: Bronchoscopy

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

Diagnostic Test: Bronchoscopy

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

Diagnostic Test: Bronchoscopy

Invasive Mechanical Ventilation (iMV)

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

Diagnostic Test: Bronchoscopy

Interventions

Bronchoscopy DIAGNOSTIC_TEST

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).

Continuous Positive Airway Pressure (CPAP); High Flow oxygen through Nasal Cannula (HFNC); Invasive Mechanical Ventilation (iMV); Non-Invasive Ventilation (NIV); Standard Oxygen Therapy (SOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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)

You may qualify if:

• Need for any procedure with flexible FOB
• Either outpatients in dedicated ambulatories, and admitted to any hospital ward or Intensive Care Unit (ICU)

You may not qualify if:

• None

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, Italy

RECRUITING

Related Publications (1)

• Longhini F, Crimi C, Noto A, Pelaia C, Karakurt Z, Skoczynski S, Boleo-Tome JP, Winck JC, Esquinas AM, Melhorn J, Corneci D, Pobeha P, Bosco V, Garofalo E, Bruni A, Cammarota G, Todorova V, Puci MV, Sotgiu G, Kostikas K, Maggiore SM, De Robertis E, Ergan B, Landoni G, Simonte R, Nava S, Navalesi P, Scala R; OxyFOB study group. Practice of oxygenation and respiratory support during fibreoptic bronchoscopy: the OxyFOB study protocol. BMJ Open. 2025 Sep 2;15(9):e104747. doi: 10.1136/bmjopen-2025-104747.

  PMID: 40897500 DERIVED

MeSH Terms

Conditions

Pneumonia; Lung Neoplasms; Pulmonary Fibrosis; Lung Diseases, Interstitial

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Federico Longhini, MD

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Longhini, MD

CONTACT

+393475395967; longhini.federico@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Intensive Care and Anesthesia Department

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 12, 2023
• Study Start: February 15, 2023
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: After study publication on a peer-reviewed journal in english language
• Access Criteria: On reasonable request to the Principal Investigator

Locations

IT (1)