NCT06180603 Strategy for Prompt and Effective Thoracentesis in the Emergency Department
| NCT ID | NCT06180603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Pleural Effusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2025-11-30 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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.
Eligibility Criteria
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