Clinical trial NCT06180603: Strategy for Prompt and Effective Thoracentesis in the Emergency Department
Official title: Strategy for Prompt and Effective Thoracentesis in the Emergency Department: A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pleural Effusion
Pleural Diseases
Heart Failure
Keywords: Thoracentesis
Emergency department
Treatment methods
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
First posted: 2023-12-22
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time from identification of the clinical indication for thoracentesis to complete drainage
timeFrame: From date and time for randomization until the date and time removal of catheter, assessed up to 3 month
Secondary outcomes:
measure: Hospital length of stay (days)
timeFrame: Date of admission until date of hospital discharge, assessed up until 3 month
measure: Duration of procedure (time)
timeFrame: from date and time for insertion until date and time for removal, assessed up until 3 month
measure: Patients degree of chest discomfort (score)
timeFrame: from date of indication until removal of catheter, assessed up until 3 month
measure: Patients degree of breathlessnesss (score)
timeFrame: from date of indication until removal of catheter, assessed up until 3 month
measure: Patients satisfaction
timeFrame: On the date of removal, assessed up until 1 month
measure: 72- hour revisit from discharged (count)
timeFrame: from date of discharge and up until 72 hours
measure: 30 days re-admission (count)
timeFrame: from date of discharge and up assessed until 30 days
measure: Complications to thoracentesis (count)
timeFrame: from insertion of catheter and assessed up until 1 week after removal of catheter
measure: Total ED admission time (days)
timeFrame: From date and time for admission until date and time for ED discharge, assessed up until 1 month
measure: Total volume drained ( ml)
timeFrame: from date of insertion of catheter until removal of catheter, assessed up until 3 month
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
city: Gødstrup
country: Denmark
facility: Gødstrup Regional Hospital
state: Central Denmark Region
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
state: Central Denmark Region
city: Randers
country: Denmark
facility: Randers Regional Hospital
state: Central Denmark Region
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: North Denmark Region
city: Esbjerg
country: Denmark
facility: Esbjerg sygehus
state: South Region Denmark
Study officials:
affiliation: Aarhus University Hospital
name: Sandra T Langsted
role: PRINCIPAL_INVESTIGATOR
References: