An interventional study of Gravity fluid drainage in the radiology department and Manual drainage in the emergency department in Pleural Effusion, Pleural Diseases and Heart Failure, sponsored by University of Aarhus. Recruiting at 6 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 188 is above the median of 80 across 142 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care thoracentesis in the radiology department ( passively drainage using gravity)
Procedure: Gravity fluid drainage in the radiology department
Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock)
Procedure: Manual drainage in the emergency department
Patients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines.
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:
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
Time frame: From date and time for randomization until the date and time removal of catheter, assessed up to 3 month
Hospital length of stay (days)
Defined as from date of admission until the date of hospital discharge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from date of discharge and up until 72 hours
30 days re-admission (count)
defined as any admission during 30 day follow-up
Time frame: from date of discharge and up assessed until 30 days
Complications to thoracentesis (count)
Number of complications to thoracentesis
Time frame: 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
Time frame: 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
Time frame: from date of insertion of catheter until removal of catheter, assessed up until 3 month
Plan to share: Yes — De-identified data necessary to reproduce published results will be made available on reasonable requests.
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.
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Nov 2025, 22 months after the start.
Of 61 non-industry interventional studies with no phase under Pleural Effusion, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's planned 22 months is below that.
Counting every sponsor, half of 63 studies reached it within 26 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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