RecruitingNot ApplicableNCT06180603

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

Sponsor

University of Aarhus

Enrollment

188 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Pleural Diseases Pleural Effusion

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria6

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

Interventions

PROCEDUREGravity fluid drainage in the radiology department

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

PROCEDUREManual 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: