Strategy for Prompt and Effective Thoracentesis in the Emergency Department

Study Overview
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Brief Summary
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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.

Official Title
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Strategy for Prompt and Effective Thoracentesis in the Emergency Department: A Multicenter Randomized Clinical Trial

Conditions
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Pleural Effusion, Pleural Diseases, Heart Failure

Intervention / Treatment
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* Procedure: Gravity fluid drainage in the radiology department
* Procedure: Manual drainage in the emergency department


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Standard of care thoracentesis in the radiology department ( passively drainage using gravity) | Procedure: Gravity fluid drainage in the radiology department<br>* Patients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines.<br>|
| Experimental: Intervention group<br>Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock) | Procedure: Manual drainage in the emergency department<br>* Thoracentesis will be performed according to current guidelines in the emergency department. Fluid will manually be drained using a syringe connected to a three-way stopcock. Thoracentesis will be stopped early if:<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from identification of the clinical indication for thoracentesis to complete drainage | Time from identification of the clinical indication for thoracentesis is defined as the time patient is randomized. The time of complete drainage is defined by removal of pigtail catheter | From date and time for randomization until the date and time removal of catheter, assessed up to 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay (days) | Defined as from date of admission until the date of hospital discharge | Date of admission until date of hospital discharge, assessed up until 3 month | 
| Duration of procedure (time) | Defined as from date and time for insertion of catheter until date and time for removal of catheter | from date and time for insertion until date and time for removal, assessed up until 3 month | 
| Patients degree of chest discomfort (score) | Chest discomfort will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter | from date of indication until removal of catheter, assessed up until 3 month | 
| Patients degree of breathlessnesss (score) | Breathlessness will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter | from date of indication until removal of catheter, assessed up until 3 month | 
| Patients satisfaction | After removal of catheter patients will be given a questionnaire | On the date of removal, assessed up until 1 month | 
| 72- hour revisit from discharged (count) | Defined as any unplanned hospital stay within 72 hours from previous hospital discharge | from date of discharge and up until 72 hours | 
| 30 days re-admission (count) | defined as any admission during 30 day follow-up | from date of discharge and up assessed until 30 days | 
| Complications to thoracentesis (count) | Number of complications to thoracentesis | from insertion of catheter and assessed up until 1 week after removal of catheter | 
| Total ED admission time (days) | Date and time for admission until date and time for ED discharge | From date and time for admission until date and time for ED discharge, assessed up until 1 month | 
| Total volume drained ( ml) | the total amount of fluid drained from insertion of catether until removal of cathether | from date of insertion of catheter until removal of catheter, assessed up until 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracentesis, Emergency department, Treatment methods