Strategy for Prompt and Effective Thoracentesis in the Emergency Department (SPEEDTAP)

December 4, 2024 updated by: University of Aarhus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
    • Central Denmark Region
      • Aarhus, Central Denmark Region, Denmark, 8200
        • Not yet recruiting
        • Aarhus University Hospital
        • Contact:
          • Nikolaj Raaber, MD, PhD
      • Gødstrup, Central Denmark Region, Denmark, 7400
        • Not yet recruiting
        • Gødstrup Regional Hospital
        • Contact:
          • Larshan Perinpam, MD
      • Horsens, Central Denmark Region, Denmark, 8700
        • Recruiting
        • Horsens Regional Hospital
        • Contact:
          • Malene Christophersen, MD
      • Randers, Central Denmark Region, Denmark, 8930
        • Recruiting
        • Randers Regional Hospital
        • Contact:
          • Sandra T Langsted, MD
    • North Denmark Region
      • Aalborg, North Denmark Region, Denmark
        • Recruiting
        • Aalborg University Hospital
        • Contact:
          • Anne Lund Krarup
    • South Region Denmark
      • Esbjerg, South Region Denmark, Denmark
        • Recruiting
        • Esbjerg Sygehus
        • Contact:
          • Peter Biesenbach, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
Standard of care thoracentesis in the radiology department ( passively drainage using gravity)
Procedure: Gravity fluid drainage in the radiology department
Patients will be referred to the radiology department. Thoracentesis will be performed according to local guidelines.
Experimental: Intervention group
Thoracentesis in the emergency department (manual fluid drainage using a syringe connected to a three-way stopcock)
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:

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From date and time for randomization until the date and time removal of catheter, assessed up to 3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital length of stay (days)
Time Frame: Date of admission until date of hospital discharge, assessed up until 3 month
Defined as from date of admission until the date of hospital discharge
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
Defined as from date and time for insertion of catheter until date and time for removal of catheter
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
Chest discomfort will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter
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
Breathlessness will be assessed using an appropiate scale before insertion of the catheter, during the procedure and after removal of catheter
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
After removal of catheter patients will be given a questionnaire
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
Defined as any unplanned hospital stay within 72 hours from previous hospital discharge
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
defined as any admission during 30 day follow-up
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
Number of complications to thoracentesis
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
Date and time for admission until date and time for ED discharge
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
the total amount of fluid drained from insertion of catether until removal of cathether
from date of insertion of catheter until removal of catheter, assessed up until 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Central Denmark Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sandra T Langsted, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AU307272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data necessary to reproduce published results will be made available on reasonable requests.

IPD Sharing Time Frame

Six months after the publication of the last results, all de-identified individual patient data will be made available upon request. There will be no predetermined end date for the data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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