Longhini Federico, Crimi Claudia, Noto Alberto, Pelaia Corrado, Karakurt Zuhal, Skoczyński Szymon, Boléo-Tomé José Pedro, Winck João Carlos, Esquinas Antonio M, Melhorn James, Corneci Dan, Pobeha Pavol, Bosco Vincenzo, Garofalo Eugenio, Bruni Andrea, Cammarota Gianmaria, Todorova Violeta, Puci Mariangela Valentina, Sotgiu Giovanni, Kostikas Konstantinos, Maggiore Salvatore Maurizio, De Robertis Edoardo, Ergan Begum, Landoni Giovanni, Simonte Rachele, Nava Stefano, Navalesi Paolo, Scala Raffaele
Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy
Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.
BMJ Open. 2025 Sep 2;15(9):e104747. doi: 10.1136/bmjopen-2025-104747.
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.
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.
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.
ClinicalTrials.gov ID: NCT05681962. Registered January 2023.
可弯曲支气管镜检查（FB）在肺病医学的诊断和治疗程序中被广泛应用。然而，FB可能会引发呼吸和血流动力学并发症，尤其是在已有肺部和/或心血管合并症的患者中。尽管有多种氧合和通气方法可用于预防这些风险，但关于它们在实际应用中的证据以及临床影响却很有限。OxyFOB研究旨在评估欧洲各地在FB期间使用的各种氧合和通气支持策略的发生率及结果。
OxyFOB研究是一项大型、前瞻性、国际性观察性队列研究，旨在纳入欧洲各中心超过10000例FB手术。符合条件的参与者包括所有因诊断、治疗或操作指征而接受FB的成年人。数据通过标准化电子病例报告表收集，涵盖人口统计学信息、操作细节和临床结果。主要终点是氧合和通气支持策略的发生率：传统氧疗、高流量氧疗、持续气道正压通气、无创通气和有创机械通气。次要结局包括围手术期呼吸和血流动力学事件、患者舒适度、呼吸困难和术后并发症。统计分析包括描述性统计、亚组比较和多变量逻辑回归。
该研究已获得协调中心（2022年1月20日，“科拉布里亚大区中心地区伦理委员会”批准的第22/2022号方案）及所有参与地点的伦理批准。所有患者或其法定代表人均已签署知情同意书。研究结果将通过同行评审出版物和在国际会议上的报告进行传播。数据将进行管理，并在合理请求时提供，以支持进一步研究。
ClinicalTrials.gov标识符：NCT05681962。于2023年1月注册。
