Comparing two methods for draining fluid from the lungs in emergency departments
Strategy for Prompt and Effective Thoracentesis in the Emergency Department: A Multicenter Randomized Clinical Trial
This study tests which method works better for draining fluid from the lungs in emergency departments: doing it manually or letting gravity do the work.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 6 sites (Aarhus, Central Jutland and 5 other locations) |
| Trial ID | NCT06180603 on ClinicalTrials.gov |
What this trial studies
The SPEEDTAP-trial is a multicenter clinical trial that investigates two different methods for performing thoracentesis in emergency departments. Patients will be randomly assigned to receive either manual fluid removal in the emergency department or passive fluid drainage using gravity in the radiology department. The primary goal is to determine which method allows for quicker drainage of pleural effusions, with secondary outcomes including length of hospital stay and safety measures. A total of 188 patients will be included in this study across four emergency departments in Central Denmark.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a clinically justified need for thoracentesis due to pleural effusion.
Not a fit: Patients experiencing life-threatening respiratory distress or those unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more effective treatment for patients with pleural effusions, improving their overall outcomes.
How similar studies have performed: Other studies have explored thoracentesis methods, but this specific comparison of manual versus gravity drainage in emergency settings is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus, Central Jutland and 5 other locations
- Aarhus University Hospital — Aarhus, Central Jutland, Denmark (Not_yet_recruiting)
- Gødstrup Regional Hospital — Gødstrup, Central Jutland, Denmark (Not_yet_recruiting)
- Horsens Regional Hospital — Horsens, Central Jutland, Denmark (Recruiting)
- Randers Regional Hospital — Randers, Central Jutland, Denmark (Recruiting)
- Aalborg University Hospital — Aalborg, North Denmark, Denmark (Recruiting)
- Esbjerg sygehus — Esbjerg, South Region Denmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Sandra T Langsted — Aarhus University Hospital
- Study coordinator: Sandra T Langsted
- Email: sandra.langsted@clin.au.dk
- Phone: +45 20 27 65 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.