Efficacy and safety outcomes of drainage of intensive care pleural effusions: Study protocol for the ESODICE randomized controlled trial

Abstract

Background: Pleural effusions are common in intensive care patients. Without strong evidence to guide management, clinicians variably undertake either intervention with drainage procedures, or expectant management, that is, observation, whilst treating the underlying cause. Early drainage may be associated with improved diagnostic accuracy and oxygenation, without increased complications. However, randomized evidence is needed to confirm these observations. Hypotheses: In patients diagnosed with a safely drainable pleural effusion while admitted to the intensive care units (ICU) and in whom there is no absolute indication for immediate drainage, intervention with early pleural drainage compared with initial expectant management: improves oxygenation and is safe. Aims: To undertake a phase II multicenter randomized controlled trial evaluating the safety and efficacy of early pleural effusion drainage compared with expectant management in the intensive care setting. Methods: Population – patients admitted in intensive care units and diagnosed with a safely drainable pleural effusion in whom there is no absolute indication for immediate drainage. Co-primary endpoints – ratio of arterial oxygen partial pressure to fraction of inspired oxygen ratio at 48 hours after randomization and number of Pleural Effusion Related Serious Adverse Events at 90 days. Inclusion criteria – admitted to intensive care, age > 18 years, pleural effusion safely drainable, and no absolute indication for immediate drainage. Exclusion criteria – in the opinion of treating clinician trial not in patient’s best interests, inability to gain consent from patient or responsible decision-maker, and patient requiring extracorporeal membrane oxygenation. Randomization – open-label, 1:1 patient ratio using permuted block randomization. Intervention and comparator – drainage of pleural effusion as opposed to expectant management. Outcomes – physiological data including ratio of arterial oxygen partial pressure to fraction of inspired oxygen and/or ratio of oxygen saturation measured by pulse oximetry to fraction of inspired oxygen ratio will be collected at randomization and 6 hourly until 72 hours or ICU discharge (whichever sooner). Adverse event and clinical data will be recorded daily to ICU discharge, hospital discharge and death up to 90 days after randomization.