A feasibility randomised trial comparing therapeutic thoracentesis to chest tube insertion for the management of pleural infection: results from the ACTion trial.

Abstract

<b>Background:</b> Pleural infection has a considerable healthcare burden with an average hospital stay of 14 days. There have been no randomised trials on the use of therapeutic thoracentesis (TT) for initial pleural fluid drainage. <b>Aim:</b> To assess the feasibility of a full-scale trial of chest tube vs TT for pleural infection. The primary outcome was defined as the acceptability of randomisation (ad priori defined as successful if ≥50% of eligible patients were randomised). <b>Methods:</b> Adult patients admitted with a pleural effusion related to infection and meeting recognised criteria for drainage were eligible. Participants were randomised (unblinded) to chest tube insertion or TT. Patients were followed up at 90 days. <b>Results:</b> From September 2019 and June 2021, 51 patients were diagnosed with complex parapneumonic effusion/empyema. Eleven patients met the inclusion criteria for trial and 10 patients were randomised (91%). The COVID-19 pandemic had a significant impact on recruitment. Patients randomised to TT had a shorter overall mean hospital stay (5.4 days, SD 5.1) compared to the chest tube control group (13 days, SD 6.0), p=0.04. Total number of pleural procedures required per patient were similar, 1.2 in chest tube group and 1.4 in TT group. No patients required surgical referral. Adverse events were similar between the groups with no readmissions related to pleural infection. Data completeness was high with no protocol deviations. <b>Conclusions:</b> The ACTion trial met its prespecified feasibility criteria for patient acceptability. The suggestion that TT can reduce hospital length of stay requires further investigation.