Drainage of Pleural Effusion in the Intensive Care Unit (DOPE-ICU) Feasibility Trial-Protocol and Statistical Analysis Plan.

Abstract

Pleural effusions are common in adult intensive care unit (ICU) patients with respiratory failure. Ultrasonography-guided therapeutic pleural drainage is widely used and associated with improved oxygenation and ventilatory parameters, but no randomised clinical trial data exist. This paper outlines the protocol and detailed statistical analysis plan for the Drainage Of Pleural Effusions in the ICU (DOPE-ICU) feasibility trial. This is an investigator-initiated, pragmatic, multicentre, open-label, randomised, parallel-group feasibility trial. Adults acutely admitted to the ICU with pleural effusion ≥ 2 cm and respiratory failure will be screened for inclusion. We will exclude patients with existing pleural or mediastinal drain, suspected or confirmed haemothorax, pneumothorax, empyema or pleural malignancy, coagulation deficiency or antithrombotic therapy incompatible with drainage, clinical indication for therapeutic pleural drainage and predefined severe hypoxaemic or hypercapnic respiratory failure, expected ICU stay < 24 h, pregnancy, imminent withdrawal of active therapy, or patients previously randomised in the trial. A total of 88 eligible patients will be allocated 1:1 to ultrasonography-guided therapeutic pleural drainage with small-bore catheter, with repeated drainage of repeated pleural effusions during ICU stay including readmissions within 90 days versus no therapeutic pleural drainage during ICU stay within 90 days unless pre-specified escape criteria apply. The primary outcome is a feasibility outcome assessing group separation, i.e., proportion of patients receiving pleural drainage in ICU within 90 days. Secondary clinical outcomes include all-cause 90-day mortality, number of patients with one or more serious adverse events within 90 days, and absolute number of days alive without life support and out of hospital, respectively, in 90 days. Additional secondary feasibility and process outcomes will also be investigated. Data will be compared in the intension-to-treat population using generalised linear models adjusted for the stratification variable trial site. ClinicalTrials.gov identifier: NCT06709456. The DOPE-ICU feasibility trial will assess whether randomised allocation to ultrasonography-guided therapeutic pleural drainage or not in adult ICU patients with respiratory failure and pleural effusion is feasible. This will inform the design of a future large randomised clinical trial evaluating the clinical effects and safety of pleural drainage in this population.