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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Pleural Diseases; Pleural Effusion
• Intervention / Treatment: Procedure: Gravity fluid drainage in the radiology department; Procedure: Manual drainage in the emergency department

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra T Langsted; Phone Number: +45 20 27 65 12; Email: sandra.langsted@clin.au.dk
• Study Contact Backup: Name: Bo Løfgren; Email: bl@clin.au.dk

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus, Central Denmark Region, Denmark, 8200
      • Not yet recruiting
      • Aarhus University Hospital
      • Contact: Nikolaj Raaber, MD, PhD
    • Gødstrup, Central Denmark Region, Denmark, 7400
      • Not yet recruiting
      • Gødstrup Regional Hospital
      • Contact: Larshan Perinpam, MD
    • Horsens, Central Denmark Region, Denmark, 8700
      • Recruiting
      • Horsens Regional Hospital
      • Contact: Malene Christophersen, MD
    • Randers, Central Denmark Region, Denmark, 8930
      • Recruiting
      • Randers Regional Hospital
      • Contact: Sandra T Langsted, MD
  • North Denmark Region
    • Aalborg, North Denmark Region, Denmark
      • Recruiting
      • Aalborg University Hospital
      • Contact: Anne Lund Krarup
  • South Region Denmark
    • Esbjerg, South Region Denmark, Denmark
      • Recruiting
      • Esbjerg Sygehus
      • Contact: Peter Biesenbach, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Standard of care thoracentesis in the radiology department ( passively drainage using gravity)	Procedure: Gravity fluid drainage in the radiology department; Patients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines.
Experimental: Intervention group; Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock)	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:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay (days)	Defined as from date of admission until the date of hospital discharge	Date of admission until date of hospital discharge, assessed up until 3 month
Duration of procedure (time)	Defined as from date and time for insertion of catheter until date and time for removal of catheter	from date and time for insertion until date and time for removal, assessed up until 3 month
Patients degree of chest discomfort (score)	Chest discomfort will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter	from date of indication until removal of catheter, assessed up until 3 month
Patients degree of breathlessnesss (score)	Breathlessness will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter	from date of indication until removal of catheter, assessed up until 3 month
Patients satisfaction	After removal of catheter patients will be given a questionnaire	On the date of removal, assessed up until 1 month
72- hour revisit from discharged (count)	Defined as any unplanned hospital stay within 72 hours from previous hospital discharge	from date of discharge and up until 72 hours
30 days re-admission (count)	defined as any admission during 30 day follow-up	from date of discharge and up assessed until 30 days
Complications to thoracentesis (count)	Number of complications to thoracentesis	from insertion of catheter and assessed up until 1 week after removal of catheter
Total ED admission time (days)	Date and time for admission until date and time for ED discharge	From date and time for admission until date and time for ED discharge, assessed up until 1 month
Total volume drained ( ml)	the total amount of fluid drained from insertion of catether until removal of cathether	from date of insertion of catheter until removal of catheter, assessed up until 3 month

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Central Denmark Region
• Investigators: Principal Investigator: Sandra T Langsted, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Emergency department; Thoracentesis; Treatment methods
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Emergencies; Pleural Effusion; Pleural Diseases
• Other Study ID Numbers: AU307272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data necessary to reproduce published results will be made available on reasonable requests.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No