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Thoracentesis QI Study

Primary Purpose

Pleural Effusion

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual aspiration
Wall suction
Vacuum bottle drainage
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion focused on measuring pleural effusion, thoracentesis, wall suction, manual aspiration, vacuum bottle drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18
  • Evidence of pleural effusion on imaging
  • Clinical indication for thoracentesis

Exclusion Criteria:

  • Age <18
  • Standard contraindication for thoracentesis procedure
  • Patients on positive pressure ventilation
  • Patients who have opted out of research in EPIC

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Manual aspiration

Wall suction

Vacuum bottle drainage

Arm Description

pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock

pleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously

pleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container

Outcomes

Primary Outcome Measures

Procedural time to 500mL
Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL
Procedural time to 750mL
Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL
Procedural time to 1L
Time to pleural fluid drainage from initiation of therapeutic drainage to 1L
Pain and dyspnea scores- Baseline
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Pain and dyspnea scores- Cath
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Pain and dyspnea scores- Post-fluid
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Pain and dyspnea scores- Post-cath
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Pain and dyspnea scores- 5m post
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Pain and dyspnea scores- 24h post
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)

Secondary Outcome Measures

Full Information

First Posted
April 25, 2022
Last Updated
June 21, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05424120
Brief Title
Thoracentesis QI Study
Official Title
Thoracentesis Quality Improvement (QI) Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Researchers will compare 3 standard of care methods of pleural fluid drainage during therapeutic thoracentesis. Patients are randomized to manual aspiration, vacuum bottle drainage or wall suction methods. Primary outcome is procedural time with secondary outcomes of pain and dyspnea scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
pleural effusion, thoracentesis, wall suction, manual aspiration, vacuum bottle drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled, non-blinded, single-center, quality improvement study to determine which method of standard of care thoracentesis (wall suctioning, manual aspiration, or vacuum drainage) has the shortest procedural time.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual aspiration
Arm Type
Active Comparator
Arm Description
pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock
Arm Title
Wall suction
Arm Type
Active Comparator
Arm Description
pleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously
Arm Title
Vacuum bottle drainage
Arm Type
Active Comparator
Arm Description
pleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container
Intervention Type
Procedure
Intervention Name(s)
Manual aspiration
Intervention Description
One option from standard of care
Intervention Type
Procedure
Intervention Name(s)
Wall suction
Intervention Description
One option from standard of care
Intervention Type
Procedure
Intervention Name(s)
Vacuum bottle drainage
Intervention Description
One option from standard of care
Primary Outcome Measure Information:
Title
Procedural time to 500mL
Description
Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL
Time Frame
Through study completion, an average of 24 hours
Title
Procedural time to 750mL
Description
Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL
Time Frame
Through study completion, an average of 24 hours
Title
Procedural time to 1L
Description
Time to pleural fluid drainage from initiation of therapeutic drainage to 1L
Time Frame
Through study completion, an average of 24 hours
Title
Pain and dyspnea scores- Baseline
Description
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Time Frame
Immediately prior to starting the thoracentesis
Title
Pain and dyspnea scores- Cath
Description
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Time Frame
Through study completion, an average of 24 hours
Title
Pain and dyspnea scores- Post-fluid
Description
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Time Frame
Through study completion, an average of 24 hours
Title
Pain and dyspnea scores- Post-cath
Description
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Time Frame
Immediately after removing the thoracentesis catheter
Title
Pain and dyspnea scores- 5m post
Description
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Time Frame
5 minutes post-procedure
Title
Pain and dyspnea scores- 24h post
Description
Patients will be asked to indicate their pain and dyspnea level verbally using the Modified Borg Scale for Dyspnea and Numerical Ratings Scale (0-10, with 10 being highest level of pain)
Time Frame
24 hours post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 Evidence of pleural effusion on imaging Clinical indication for thoracentesis Exclusion Criteria: Age <18 Standard contraindication for thoracentesis procedure Patients on positive pressure ventilation Patients who have opted out of research in EPIC
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Capp, MD
Phone
717-309-9829
Email
capp0044@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Cho, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Capp, MD
Phone
717-309-9829
Email
capp0044@umn.edu

12. IPD Sharing Statement

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Thoracentesis QI Study

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