This trial evaluates the feasibility of ultrasound-guided pleural drainage versus no drainage in adult ICU patients with pleural effusions (fluid buildup around the lungs) and respiratory failure. Half of the patients will undergo drainage, while the other half will not unless their condition worsens to a prespecified degree. Outcomes include feasibility measures, clinical parameters, mortality, serious adverse events, and life support use over 90 days.
Pleural effusions are common in intensive care unit (ICU) patients and are often treated with fluid drainage guided by ultrasonography. While this can improve oxygenantion levels, it is unclear whether it leads to better overall outcomes, and the procedure carries risks such as bleeding or lung collapse. There is limited evidence and no randomised trials supporting this procedure in ICU patients with respiratory failure. The DOPE-ICU feasibility trial will assess the feasibility of evaluating pleural drainage in such patients. Eligible ICU patients will be randomly assigned to either receive drainage or no drainage unless their condition worsens to a prespecified degree. Feasibility outcomes include the proportion of patients receiving drainage, protocol adherence, and proportion of patients with consent withdrawal for follow-up. Clinical outcomes include death rates, serious adverse events, and life support use, all within 90 days. Process outcomes include oxygenation, pH and arterial carbon dioxide tension at prespecified time points. The trial aims to determine whether a larger, more definitive trial is feasible.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
Ultrasonography-guided pleural drainage with insertion of a small-bore intrapleural catheter. Contralateral and repeated drainage conducted as specified during ICU stay until day 90.
Department of Anaesthesia and Intensive Care, Aalborg University Hospital
Aalborg, Denmark
RECRUITINGICU department 4131, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
RECRUITINGDepartment of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Hillerød
Intervention group separation (feasibility)
Proportion of patients receiving pleural drainage during ICU stay
Time frame: 90 days
Protocol adhearence (feasibility)
Proportion of patients with one or more protocol violations defined as: * Participants allocated to pleural drainage who do not receive this within 24 hours from randomisation. * Participants allocated to pleural drainage with bilateral pleural effusion who do not receive the second (contralateral) pleural drainage within 24 hours from the primary drainage, unless pleural effusion has receded \< 2 cm. * Participants allocated to no pleural drainage who receive pleural drainage at any time during ICU stay within 90 days from randomisation, including ICU readmissions, except when escape criteria for pleural drainage are present as specified (se "No intervention" arm).
Time frame: 90 days
Recruitment proportion (feasibility)
Proportion of included patients out of the number of eligible patients, i.e., patients who comply with all inclusion and exclusion criteria
Time frame: Through trial completion, estimated at 1 year.
Loss to follow-up (feasibility)
Proportion of participants without consent to the use of data
Time frame: 90 days
All-cause mortality (clinical outcome)
All-cause mortality
Time frame: 90 days
Serious adverse events (clinical outcome)
Proportion of patients with one or more serious adverse events (SAEs); SAEs are defined as new pneumothorax requiring invasive treatment (drainage or surgery), new haemothorax requiring red blood cell transfusion, new blood stream infection defined as any cultured microorganism from any blood sample except microorganisms clearly specified to be contaminants or likely contaminants by the microbiological department, and new episode of invasive mechanical ventilation defined as endotracheal intubation or re-intubation after extubation or tracheal decannulation.
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Hillerød, Denmark
Department of Anaesthesiology and Intensive Care Medicine, Sygehus Lillebælt, Kolding
Kolding, Denmark
RECRUITINGDepartment of Anaesthesia and Intensive Care, Zealand University Hospital, Køge
Køge, Denmark
NOT_YET_RECRUITINGDepartment of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde
Roskilde, Denmark
NOT_YET_RECRUITINGTime frame: 90 days
Days alive without life support (clinical outcome)
Absolute number of days alive without life support being the use of mechanical ventilation, renal replacement therapy, or circulatory support
Time frame: 90 days
Days alive and out of hospital (clinical outcome)
Absolute number of days alive and out of hospital
Time frame: 90 days
Pleural infections (process outcome)
Proportion of patients with new pleural infection after 24 hours from randomisation defined as any positive pleural fluid culture of any fungi or bacteria in any pleural fluid sampling conducted, except coagulase-negative Staphylococci, Enterococci, and Corynebacterium species, which will be considered contaminants.
Time frame: After 24 hours and within 90 days from randomisation
24-hour oxygenation (process outcome)
PaO2/FiO2 ratio in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.
Time frame: 24 hours
72-hour oxygenation (process outcome)
PaO2/FiO2 ratio in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.
Time frame: 72 hours
24-hour pH (process outcome)
pH in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.
Time frame: 24 hours
72-hour pH (process outcome)
pH in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.
Time frame: 72 hours
24-hour carbon dioxide (process outcome)
PaCO2 in the arterial blood gas analysis conducted in ICU closest to 24 hours after randomisation.
Time frame: 24 hours
72-hour carbon dioxide (process outcome)
PaCO2 in the arterial blood gas analysis conducted in ICU closest to 72 hours after randomisation.
Time frame: 72 hours