Pleural EffusionSPEEDTAPNCT06180603
Strategy for Prompt and Effective Thoracentesis in the Emergency Department
A study testing Gravity fluid drainage in the radiology department and Manual drainage in the emergency department in people with Pleural Effusion and Pleural Diseases, run by University of Aarhus at 6 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Pleural Diseases, Heart Failure
- What is being tested?
- Gravity fluid drainage in the radiology department and Manual drainage in the emergency department
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 6 sitesDenmark
- Study dates
- 15 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bo Løfgren contact
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, North Denmark
Anne Lund Krarup
- Not yet recruiting
Aarhus University Hospital
Aarhus, Central Jutland, 8200
Nikolaj Raaber, MD, PhD
- Recruiting
Esbjerg sygehus
Esbjerg, South Region Denmark
Peter Biesenbach, MD,PhD
- Not yet recruiting
Gødstrup Regional Hospital
Gødstrup, Central Jutland, 7400
Larshan Perinpam, MD
- Recruiting
Horsens Regional Hospital
Horsens, Central Jutland, 8700
Malene Christophersen, MD
- Recruiting
Randers Regional Hospital
Randers, Central Jutland, 8930
Sandra T Langsted, MD
About this study
Official title: Strategy for Prompt and Effective Thoracentesis in the Emergency Department: A Multicenter Randomized Clinical 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.
- Conditions
- Pleural Effusion, Pleural Diseases, Heart Failure
- Being tested
- Gravity fluid drainage in the radiology department, Manual drainage in the emergency department
- Keywords
- Thoracentesis, Emergency department, Treatment methods
- Medical subject headings
- Pleural Effusion, Pleural Diseases, Heart Failure, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gravity fluid drainage in the radiology departmentProcedure or surgery
Patients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines.
Manual drainage in the emergency departmentProcedure or 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:
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard of care thoracentesis in the radiology department ( passively drainage using gravity) Receives: Procedure: Gravity fluid drainage in the radiology department |
| Intervention group | Experimental | Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock) Receives: Procedure: Manual drainage in the emergency department |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From date and time for randomization until the date and time removal of catheter, assessed up to 3 month
Secondary outcomes (10)
Hospital length of stay (days)
Defined as from date of admission until the date of hospital discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: from date of discharge and up until 72 hours
30 days re-admission (count)
defined as any admission during 30 day follow-up
Measured: from date of discharge and up assessed until 30 days
Complications to thoracentesis (count)
Number of complications to thoracentesis
Measured: 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
Measured: 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
Measured: from date of insertion of catheter until removal of catheter, assessed up until 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start15 Jan 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Sandra T Langsted, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180603
- Sponsor's protocol ID
- AU307272
- Acronym
- SPEEDTAP
- Status last verified
- Dec 2024
- First submitted
- 9 Nov 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data necessary to reproduce published results will be made available on reasonable requests.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Prompt and Effective Thoracentesis in the Emergency Department: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06180603
- Acronym / sponsor ID
- SPEEDTAP / AU307272
- Conditions
- Pleural Effusion, Pleural Diseases, Heart Failure
- Keywords
- Thoracentesis, Emergency department, Treatment methods
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Gravity fluid drainage in the radiology departmentStandard of care thoracentesis in the radiology department ( passively drainage using gravity) |
| Intervention group | Experimental | Procedure: Manual drainage in the emergency departmentThoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gravity fluid drainage in the radiology departmentPatients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines. | Procedure or surgery | Control group |
| Manual drainage in the emergency departmentThoracentesis 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: | Procedure or surgery | Intervention group |
Primary outcome
Time from identification of the clinical indication for thoracentesis to complete drainage
Time frame: From date and time for randomization until the date and time removal of catheter, assessed up to 3 month
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
10 secondary outcomes
Hospital length of stay (days)
Time frame: Date of admission until date of hospital discharge, assessed up until 3 month
Duration of procedure (time)
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)
Time frame: from date of indication until removal of catheter, assessed up until 3 month
Patients degree of breathlessnesss (score)
Time frame: from date of indication until removal of catheter, assessed up until 3 month
Patients satisfaction
Time frame: On the date of removal, assessed up until 1 month
72- hour revisit from discharged (count)
Time frame: from date of discharge and up until 72 hours
30 days re-admission (count)
Time frame: from date of discharge and up assessed until 30 days
Complications to thoracentesis (count)
Time frame: from insertion of catheter and assessed up until 1 week after removal of catheter
Total ED admission time (days)
Time frame: From date and time for admission until date and time for ED discharge, assessed up until 1 month
Total volume drained ( ml)
Time frame: from date of insertion of catheter until removal of catheter, assessed up until 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Yes. De-identified data necessary to reproduce published results will be made available on reasonable requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Løfgren contact
Sandra T Langsted principal investigator
Aarhus University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gravity fluid drainage in the radiology department and Manual drainage in the emergency department in people with Pleural Effusion and Pleural Diseases, run by University of Aarhus at 6 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra T Langsted (+45 20 27 65 12, sandra.langsted@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from identification of the clinical indication for thoracentesis to complete drainage (time frame: From date and time for randomization until the date and time removal of catheter, assessed up to 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.