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NCT Number: NCT06180603

Strategy for Prompt and Effective Thoracentesis in the Emergency Department

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.

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Key information

Conditions

Pleural Effusion Cardiovascular Diseases Disease Attributes Emergencies Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Central Jutland, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gravity fluid drainage in the radiology department

Procedure

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

Manual drainage in the emergency department

Procedure

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 outcomes

  1. 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

    Time from identification of the clinical indication for thoracentesis is defined as the time patient is randomized. The time of complete drainage is defined by removal of pigtail catheter

Secondary outcomes

  1. Hospital length of stay (days)

    Time frame: Date of admission until date of hospital discharge, assessed up until 3 month

    Defined as from date of admission until the date of hospital discharge

  2. Duration of procedure (time)

    Time frame: from date and time for insertion until date and time for removal, assessed up until 3 month

    Defined as from date and time for insertion of catheter until date and time for removal of catheter

  3. Patients degree of chest discomfort (score)

    Time frame: from date of indication until removal of catheter, assessed up until 3 month

    Chest discomfort will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter

  4. Patients degree of breathlessnesss (score)

    Time frame: from date of indication until removal of catheter, assessed up until 3 month

    Breathlessness will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter

  5. Patients satisfaction

    Time frame: On the date of removal, assessed up until 1 month

    After removal of catheter patients will be given a questionnaire

  6. 72- hour revisit from discharged (count)

    Time frame: from date of discharge and up until 72 hours

    Defined as any unplanned hospital stay within 72 hours from previous hospital discharge

  7. 30 days re-admission (count)

    Time frame: from date of discharge and up assessed until 30 days

    defined as any admission during 30 day follow-up

  8. Complications to thoracentesis (count)

    Time frame: from insertion of catheter and assessed up until 1 week after removal of catheter

    Number of complications to thoracentesis

  9. 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

    Date and time for admission until date and time for ED discharge

  10. Total volume drained ( ml)

    Time frame: from date of insertion of catheter until removal of catheter, assessed up until 3 month

    the total amount of fluid drained from insertion of catether until removal of cathether

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Løfgren

CONTACT

[email protected]

Sandra T Langsted

CONTACT

[email protected]

+45 20 27 65 12

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region

Registry information

Official study title

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

Acronym: SPEEDTAP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 22, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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