Health TrialsbyHealthPanel

Strategy for Prompt and Effective Thoracentesis in the Emergency Department

ConditionsPleural EffusionPleural DiseasesHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Life-threatening respiratory distress

Not able to give consent

Previous pleurodesis

Effusion does not appear free-flowing due to septations or loculations / suspected empyema

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gravity fluid drainage in the radiology department

    Procedure/Surgery

    Patients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines.

  • Manual drainage in the emergency department

    Procedure/Surgery

    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:

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Central Denmark Region

Collaborator

Source ClinicalTrials.gov
Apply now