Strategy for Prompt and Effective Thoracentesis in the Emergency Department

NCT06180603 | Recruiting

• 1 other identifier: AU307272
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Pleural Effusion; Pleural Diseases; Heart Failure

Keywords

Thoracentesis; Emergency department; Treatment methods

Outcome Measures

Primary Outcomes (1)

• Time from identification of the clinical indication for thoracentesis to complete drainage

  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

  From date and time for randomization until the date and time removal of catheter, assessed up to 3 month

Secondary Outcomes (10)

• Hospital length of stay (days)

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

• Duration of procedure (time)

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

• Patients degree of chest discomfort (score)

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

• Patients degree of breathlessnesss (score)

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

• Patients satisfaction

  On the date of removal, assessed up until 1 month

Study Arms (2)

Control group

ACTIVE COMPARATOR

Standard of care thoracentesis in the radiology department ( passively drainage using gravity)

Procedure: Gravity fluid drainage in the radiology department

Intervention group

EXPERIMENTAL

Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock)

Procedure: Manual drainage in the emergency department

Interventions

Gravity fluid drainage in the radiology department PROCEDURE

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

Control group

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:

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator

Study Sites (6)

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

NOT YET RECRUITING

Gødstrup Regional Hospital

Gødstrup, Central Jutland, 7400, Denmark

NOT YET RECRUITING

Horsens Regional Hospital

Horsens, Central Jutland, 8700, Denmark

RECRUITING

Randers Regional Hospital

Randers, Central Jutland, 8930, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, North Denmark, Denmark

RECRUITING

Esbjerg sygehus

Esbjerg, South Region Denmark, Denmark

RECRUITING

MeSH Terms

Conditions

Pleural Effusion; Pleural Diseases; Heart Failure; Emergencies

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra T Langsted

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra T Langsted

CONTACT

+45 20 27 65 12; sandra.langsted@clin.au.dk

Bo Løfgren

CONTACT

bl@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: December 22, 2023
• Study Start: January 15, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Six months after the publication of the last results, all de-identified individual patient data will be made available upon request. There will be no predetermined end date for the data sharing.

Locations

DK (6)