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

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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)

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

Trial contacts and locations

6

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Central trial contact

Bo Løfgren; Sandra T Langsted

Data sourced from clinicaltrials.gov

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