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.

Exacerbations of chronic obstructive pulmonary disease (COPD) can lead to reduced lung function and worse clinical outcomes. Previous studies have reported associations between severe exacerbations and increased risk of hospitalisation and/or mortality. This meta-analysis examined the impact of moderate exacerbations on the risk of future exacerbations and all-cause mortality.

This meta-analysis included seven observational studies from the EXACOS (EXAcerbations of COPD and their OutcomeS)/AVOIDEX (Impact of AVOIDing EXacerbations of COPD) programme studies.

This meta-analysis used data from regional claims databases or electronic healthcare records from seven countries.

The individual studies included patients with a diagnosis of COPD and ≥12 months of data availability before (regarded as baseline) and after the index (ie, the date of the first COPD diagnosis), with postindex data considered the follow-up period.

The number of COPD exacerbations experienced during the baseline period (ie, the exposure variable) was used to categorise patients into the following groups: no exacerbations, one moderate exacerbation only or two or more moderate/severe exacerbations. Outcomes assessed included risk of COPD exacerbations and all-cause mortality during follow-up as a function of baseline exacerbations. For meta-analyses, all rate ratios (RRs) were log-transformed, and associations were pooled across studies using random-effects meta-analysis models.

Among 2 733 162 patients with COPD, one moderate exacerbation was significantly associated with a twofold increased risk of future exacerbations compared with having no exacerbations during baseline, with pooled RRs (95% CIs) of 2.47 (1.47 to 4.14) at 1 year, 2.49 (1.38 to 4.49) at 2 years and 2.38 (1.30 to 4.34) at 3 years postindex. The pooled RR (95% CI) for all-cause mortality was 1.30 (1.05 to 1.62), indicating a 30% increase in risk following one moderate exacerbation versus no exacerbations.

Preventing moderate exacerbations in patients with COPD should be a priority that may improve patient trajectories and outcomes.