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Recruiting NCT06180603

Strategy for Prompt and Effective Thoracentesis in the Emergency Department

No phase Interventional Pleural Effusion Pleural Diseases Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gravity fluid drainage in the radiology department, Manual drainage in the emergency department.
Who it may be relevant to
Registry conditions: Pleural Effusion, Pleural Diseases, Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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:

Primary outcome measures

  • Time from identification of the clinical indication for thoracentesis to complete drainage [Time frame: From date and time for randomization until the date and time removal of catheter, assessed up to 3 month]
Secondary outcome measures (10)
  • Hospital length of stay (days) [Time frame: Date of admission until date of hospital discharge, assessed up until 3 month]
  • Duration of procedure (time) [Time frame: from date and time for insertion until date and time for removal, assessed up until 3 month]
  • Patients degree of chest discomfort (score) [Time frame: from date of indication until removal of catheter, assessed up until 3 month]
  • Patients degree of breathlessnesss (score) [Time frame: from date of indication until removal of catheter, assessed up until 3 month]
  • Patients satisfaction [Time frame: On the date of removal, assessed up until 1 month]
  • 72- hour revisit from discharged (count) [Time frame: from date of discharge and up until 72 hours]
  • 30 days re-admission (count) [Time frame: from date of discharge and up assessed until 30 days]
  • Complications to thoracentesis (count) [Time frame: from insertion of catheter and assessed up until 1 week after removal of catheter]
  • Total ED admission time (days) [Time frame: From date and time for admission until date and time for ED discharge, assessed up until 1 month]
  • Total volume drained ( ml) [Time frame: from date of insertion of catheter until removal of catheter, assessed up until 3 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 6 centers
  • Aarhus University Hospital — Aarhus
  • Gødstrup Regional Hospital — Gødstrup
  • Horsens Regional Hospital — Horsens
  • Randers Regional Hospital — Randers
  • Aalborg University Hospital — Aalborg
  • Esbjerg sygehus — Esbjerg

Identifiers

NCT: NCT06180603 · AU307272

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗