Practice of oxygenation and respiratory support during fibreoptic bronchoscopy: the OxyFOB study protocol
- PMID: 40897500
- PMCID: PMC12410610
- DOI: 10.1136/bmjopen-2025-104747
Practice of oxygenation and respiratory support during fibreoptic bronchoscopy: the OxyFOB study protocol
Abstract
Introduction: Flexible bronchoscopy (FB) is widely used for diagnostic and therapeutic procedures in pulmonary medicine. However, FB can cause respiratory and haemodynamic complications, especially in patients with pre-existing lung and/or cardiovascular comorbidities. Despite the range of oxygenation and ventilatory approaches available to prevent these risks, evidence regarding their real-world application and clinical impact is limited. The OxyFOB study aims to assess the prevalence and outcomes of various oxygenation and ventilatory support strategies used during FB across Europe.
Methods and analysis: The OxyFOB study is a large, prospective, international, observational cohort study which aims to involve over 10 000 FB procedures across European centres. Eligible participants include all adults undergoing FB for diagnostic, therapeutic or procedural indications. Data are collected via a standardised electronic case report form and encompass demographic information, procedural details and clinical outcomes. The primary endpoint is the prevalence of oxygenation and ventilatory support strategies: conventional oxygen therapy, high-flow oxygen therapy, continuous positive airway pressure, non-invasive ventilation and invasive mechanical ventilation. Secondary outcomes include periprocedural respiratory and haemodynamic events, patient comfort, dyspnoea and postprocedural complications. Statistical analyses include descriptive statistics, subgroup comparisons and multivariate logistic regression.
Ethics and dissemination: The study has received ethical approval from the coordinating centre (protocol n. 22/2022 on the 20 January 2022, by the 'Comitato Etico Sezione Area Centro - Regione Calabria') and all participating sites. Informed consent is given from all patients or their legal representatives. Findings will be disseminated through peer-reviewed publications and presentations at international meetings. Data will be managed and made available on reasonable request to support further research.
Trial registration number: ClinicalTrials.gov ID: NCT05681962. Registered January 2023.
Keywords: Bronchoscopy; Oxygen Saturation; Ventilators, Mechanical.
© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.
Conflict of interest statement
Competing interests: Dr. FL contributed to the development of a new device for non-invasive ventilation not discussed in the present study (European Patent number 3320941). He also received honoraria from Draeger, Intersurgical, Fisher & Paykel, AOP and Medicair. Dr CC received speaking honoraria from Fisher & Paykel, Philips, Resmed and Vitalaire. Dr. CP has received lecture fees and advisory board fees from AstraZeneca, GlaxoSmithKline, Sanofi-Regeneron, Chiesi. JPBT received travel grants and economical support to attend training courses from Pentax Medical Iberia. Prof. JCW received from Philips-Respironics (fees for lecturing, participation in advisory board, reimbursement for Congress), ResMed (fees for lecturing) and Fisher-Paykel (fees for lecturing). Dr. PP received speaking honoraria from Angelini Pharma, Philiphs, Berlin-Chemie, Astra Zeneca and CSL Behring. Dr GC received travel grants from Draeger. GS received speaking fee from Pfizer, Quiagen, AZ and INSMED. Dr. KK received honoraria for presentations and/or consultancy fees from AstraZeneca, Berlin-Chemie, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Guidotti, Menarini, Pfizer, Sanofi, and Specialty Therapeutics. His department has received funding and/or grants from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Menarini. He also worked with AstraZeneca as Global Medical Head Respiratory Biologics and he is a member of the GOLD Assembly. SMM received lecture's fee from GE Healthcare. Dr. EDR received honoraria lectures from Draeger, Fisher & Paykel, Baxter and GE. Dr. BE received honoraria lectures from Fisher & Paykel and Breas. Dr. PN received grants/research equipment from Draeger, Intersurgical SPA, and Gilead and speaking fees from Getinge, Mindray, Intersurgical SPA, Gilead, GSK and Draeger. The remaining authors have no conflict of interest to disclose related to the present work.
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