None listed
Conditions
Brief summary
The ESODICE trial is a Phase 2 open label randomised trial of drainage of pleural effusion in patients admitted to an intensive care unit. Coprimary endpoints are: a) safety, determined by rates of pleural effusion related serious adverse events at the earlier of 90 days or hospital discharge; b) efficacy, defined as statistically significant improvement in P:F ratio at 48 hours compared to randomisation.
Interventions
Drainage of the pleural fluid through an intercostal catheter inserted into the pleural space. This procedure will be performed by the treating intenisive care clinician who has been trained in this procedure. This procedure is considered a routine core skill for intensive care training. Ultrasound guidance will be used for insertion (this can be real-time or “x marks the spot” but the latter only with the patient in the exact position that drainage will occur and with marking occurring within 1
Drainage of the pleural fluid through an intercostal catheter inserted into the pleural space. This procedure will be performed by the treating intenisive care clinician who has been trained in this procedure. This procedure is considered a routine core skill for intensive care training. Ultrasound guidance will be used for insertion (this can be real-time or “x marks the spot” but the latter only with the patient in the exact position that drainage will occur and with marking occurring within 15 minutes of skin puncture). The choice of drain size and drainage technique (blunt, modified Seldinger, or thoracentesis) will be left to the discretion of the treating clinician. Complete evacuation of the fluid will be attempted and if that requires insertion of a second drainage tube that will be allowed as required as per normal practice. This treatment is externally obvious to all caring for the patient and therefore treatment allocation cannot be concealed/blinded. The procedure takes 20 to 40 minutes on average.
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Admitted to intensive care. 2. Aged 18 years or older. 3. Diagnosed with a safely drainable pleural effusion. 4. No absolute contraindication to immediate drainage present.
Exclusion criteria
1. In the opinion of the treating clinician the trial is not in the patient’s best interests. 2. Patient requiring extracorporeal membrane oxygenation. 3. Inability to obtain informed consent from either the patient or their responsible decision-maker.
Outcome results
None listed