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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
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:
Aarhus University Hospital
Aarhus, Central Jutland, Denmark
NOT_YET_RECRUITINGGødstrup Regional Hospital
Gødstrup, Central Jutland, Denmark
NOT_YET_RECRUITINGHorsens Regional Hospital
Horsens, Central Jutland, Denmark
RECRUITINGRanders Regional Hospital
Randers, Central Jutland, Denmark
RECRUITINGAalborg University Hospital
Aalborg, North Denmark, Denmark
RECRUITINGEsbjerg sygehus
Esbjerg, South Region Denmark, Denmark
RECRUITINGTime 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
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