Strategy for Prompt and Effective Thoracentesis in the Emergency Department
Recruiting · NCT06180603 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →Interventions studied
Gravity fluid drainage in the radiology departmentManual drainage in the emergency department
What this trial is about
The SPEEDTAP-trial is a prospective, randomised, investigator-initiated, multicenter, clinical superior trial investigating two thoracentesis methods in four emergency departments (ED) in Central Denmark Region. Patients are randomised to either manual fluid removal in the ED or passively fluid drainage using gravity in the radiology department (standard of care). Primary outcome: time from clinical indication to complete drainage and 188 patients will be included. Key secondary outcomes include length of stay, ED admission to ED discharge and safety end-points.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients ≥ 18 years admitted to the ED
- Pleural effusion detected by any imaging modality (e.g., bedside ultrasound, chest x-ray, computed tomography)
- Clinically justified need for thoracentesis ( symptomatic relief and/or define the etiology of the effusion
- Without contraindication for thoracentesis in the emergency department (e.g., anticoagulant treatment)
Exclusion criteria
- Life-threatening respiratory distress
- Not able to give consent
- Previous pleurodesis
- Effusion does not appear free-flowing due to septations or loculations / suspected empyema
- Prior enrollment in the trial
- If randomization is not possible because decision to insert a pigtail catheter is made in the radiology department
Where it is running
6 locations listed.
- Aarhus University Hospital - Aarhus, Central Jutland, Denmark
- Gødstrup Regional Hospital - Gødstrup, Central Jutland, Denmark
- Horsens Regional Hospital - Horsens, Central Jutland, Denmark
- Randers Regional Hospital - Randers, Central Jutland, Denmark
- Aalborg University Hospital - Aalborg, North Denmark, Denmark
- Esbjerg sygehus - Esbjerg, South Region Denmark, Denmark