Strategy for Prompt and Effective Thoracentesis in the Emergency Department

NCT ID: NCT06180603

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pleural Effusion Pleural Diseases Heart Failure

Keywords

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Thoracentesis Emergency department Treatment methods

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Standard of care thoracentesis in the radiology department ( passively drainage using gravity)

Group Type ACTIVE_COMPARATOR

Gravity fluid drainage in the radiology department

Intervention Type PROCEDURE

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

Intervention group

Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock)

Group Type EXPERIMENTAL

Manual drainage in the emergency department

Intervention Type PROCEDURE

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:

Interventions

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Gravity fluid drainage in the radiology department

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

Intervention Type PROCEDURE

Manual drainage in the emergency department

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:

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Denmark Region

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra T Langsted

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Site Status NOT_YET_RECRUITING

Gødstrup Regional Hospital

Gødstrup, Central Jutland, Denmark

Site Status NOT_YET_RECRUITING

Horsens Regional Hospital

Horsens, Central Jutland, Denmark

Site Status RECRUITING

Randers Regional Hospital

Randers, Central Jutland, Denmark

Site Status RECRUITING

Aalborg University Hospital

Aalborg, North Denmark, Denmark

Site Status RECRUITING

Esbjerg sygehus

Esbjerg, South Region Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sandra T Langsted

Role: CONTACT

Phone: +45 20 27 65 12

Email: [email protected]

Bo Løfgren

Role: CONTACT

Email: [email protected]

Facility Contacts

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Nikolaj Raaber, MD, PhD

Role: primary

Larshan Perinpam, MD

Role: primary

Malene Christophersen, MD

Role: primary

Sandra T Langsted, MD

Role: primary

Anne Lund Krarup

Role: primary

Peter Biesenbach, MD,PhD

Role: primary

Other Identifiers

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AU307272

Identifier Type: -

Identifier Source: org_study_id