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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06180603
Other study ID # AU307272
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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