Strategy for Prompt and Effective Thoracentesis in the Emergency Department (SPEEDTAP)

University of Aarhus

Status: Enrolling

Conditions: Pleural Effusion; Pleural Diseases; Heart Failure

Treatments: Procedure: Gravity fluid drainage in the radiology department; Procedure: Manual drainage in the emergency department

Study type: Interventional

Funder types: Other

Identifiers

NCT06180603

AU307272

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Control group

Active Comparator group

Description:

Standard of care thoracentesis in the radiology department ( passively drainage using gravity)

Treatment:

Procedure: Gravity fluid drainage in the radiology department

Intervention group

Experimental group

Description:

Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock)

Treatment:

Procedure: Manual drainage in the emergency department