Strategy for Prompt and Effective Thoracentesis in the Emergency Department

Not Applicable

Recruiting

• Conditions: Heart Failure; Pleural Effusion; Pleural Diseases
• Interventions: Procedure: Manual drainage in the emergency department; Procedure: Gravity fluid drainage in the radiology department

• Registration Number: NCT06180603
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-12-12
• Study First Posted: 2023-12-22
• Study Start: 2024-01-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Manual drainage in the emergency department	Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock)
Control group	Gravity fluid drainage in the radiology department	Standard of care thoracentesis in the radiology department ( passively drainage using gravity)

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Aarhus University Hospital; 🇩🇰 Aarhus, Central Denmark Region, Denmark

Gødstrup Regional Hospital; 🇩🇰 Gødstrup, Central Denmark Region, Denmark

Horsens Regional Hospital; 🇩🇰 Horsens, Central Denmark Region, Denmark

Randers Regional Hospital; 🇩🇰 Randers, Central Denmark Region, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, North Denmark Region, Denmark

Esbjerg sygehus; 🇩🇰 Esbjerg, South Region Denmark, Denmark