RECRUITINGINTERVENTIONAL

Strategy for Prompt and Effective Thoracentesis in the Emergency Department

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

Gravity fluid drainage in the radiology department

Patients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines.

PROCEDURE

Manual drainage in the emergency department

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:

Locations (6)

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Gødstrup Regional Hospital

Gødstrup, Central Jutland, Denmark

Horsens Regional Hospital

Horsens, Central Jutland, Denmark

Randers Regional Hospital

Randers, Central Jutland, Denmark

Aalborg University Hospital

Aalborg, North Denmark, Denmark

Esbjerg sygehus

Esbjerg, South Region Denmark, Denmark