RecruitingRecruiting
Strategy for Prompt and Effective Thoracentesis in the Emergency Department
NCT06180603 · University of Aarhus
In plain English
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Official title
Strategy for Prompt and Effective Thoracentesis in the Emergency Department: A Multicenter Randomized Clinical Trial
About this study
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
Study design
Enrollment target: 188 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-01-15
Estimated completion: 2025-12-31
Last updated: 2024-12-05
Interventions
Procedure: Gravity fluid drainage in the radiology departmentProcedure: Manual drainage in the emergency department
Primary outcomes
- • Time from identification of the clinical indication for thoracentesis to complete drainage (From date and time for randomization until the date and time removal of catheter, assessed up to 3 month)
Sponsor
University of Aarhus · other
With: Central Denmark Region
Contacts & investigators
ContactSandra T Langsted · contact · sandra.langsted@clin.au.dk · +45 20 27 65 12
ContactBo Løfgren · contact · bl@clin.au.dk
InvestigatorSandra T Langsted · principal_investigator, Aarhus University Hospital
All locations (6)
Aarhus University HospitalNot Yet Recruiting
Aarhus, Central Jutland, Denmark
Gødstrup Regional HospitalNot Yet Recruiting
Gødstrup, Central Jutland, Denmark
Horsens Regional HospitalRecruiting
Horsens, Central Jutland, Denmark
Randers Regional HospitalRecruiting
Randers, Central Jutland, Denmark
Aalborg University HospitalRecruiting
Aalborg, North Denmark, Denmark
Esbjerg sygehusRecruiting
Esbjerg, South Region Denmark, Denmark