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.

Point-of-care lung ultrasound (LUS) can assist in diagnosing acute respiratory diseases for its high accuracy and immediate availability at the bedside, including older patients with frailty. Delirium represents a frequent complication of hospitalisation in this setting, frequently triggered by acute respiratory diseases. LUS may therefore help identify individuals at risk of delirium, but the association between LUS abnormalities and delirium remains unexplored.

This study is a prospective, observational, multicentre study, with the main objective of assessing the correlation between LUS abnormalities and incident delirium during hospitalisation (primary outcome). The secondary objectives are to assess correlations between lung and diaphragm ultrasound parameters and clinical outcomes including duration of delirium, severity of respiratory failure and mortality. 480 patients aged ≥65 years old, urgently hospitalised after an emergency department visit for acute respiratory complaints, will be recruited in eleven acute geriatric wards located in eight teaching hospitals across Italy. LUS examinations will be performed by skilled clinicians prior to treatment whenever feasible, and in any case within 48 hours from admission. They will also undergo comprehensive geriatric assessment, and daily delirium assessment through the 4-AT tool. The association between LUS abnormalities, related parameters (LUS score, Pleural Effusion Score) and outcomes will be assessed by linear and logistic regression models.

Ethics Committee approval of the coordinating centre (Comitato Etico Territoriale Lombardia 3, reference ID 4369_20.03.2024_M) and collaborative centres has been obtained. All participants will provide written informed consent. Study results will be publicly available following peer-reviewed publication in international scientific journals.

NCT06670118.