Strategy for Prompt and Effective Thoracentesis in the Emergency Department

Heart Failure Clinical Trial

— SPEEDTAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180603
• Other study ID #: AU307272
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: Sandra T Langsted
• Phone: +45 20 27 65 12
• Email: sandra.langsted[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: October 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Heart Failure
• Pleural Diseases
• Pleural Effusion

Intervention

Procedure:
• Gravity fluid drainage in the radiology department
Patients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines.
• 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:

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Denmark Region
Denmark	Gødstrup Regional Hospital	Gødstrup	Central Denmark Region
Denmark	Horsens Regional Hospital	Horsens	Central Denmark Region
Denmark	Randers Regional Hospital	Randers	Central Denmark Region

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patients satisfaction	After removal of catheter patients will be given a questionnaire	On the date of removal, assessed up until 1 month
Secondary	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
Secondary	30 days re-admission (count)	defined as any admission during 30 day follow-up	from date of discharge and up assessed until 30 days
Secondary	Complications to thoracentesis (count)	Number of complications to thoracentesis	from insertion of catheter and assessed up until 1 week after removal of catheter
Secondary	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
Secondary	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