Thoracentesis QI Study

Thoracentesis Quality Improvement (QI) Study

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion
• Intervention / Treatment: Procedure: Manual aspiration; Procedure: Wall suction; Procedure: Vacuum bottle drainage

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Capp, MD; Phone Number: 717-309-9829; Email: capp0044@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual aspiration; pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock	Procedure: Manual aspiration; One option from standard of care
Active Comparator: Wall suction; pleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously	Procedure: Wall suction; One option from standard of care
Active Comparator: Vacuum bottle drainage; pleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container	Procedure: Vacuum bottle drainage; One option from standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time to 500mL	Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL	Through study completion, an average of 24 hours
Procedural time to 750mL	Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL	Through study completion, an average of 24 hours
Procedural time to 1L	Time to pleural fluid drainage from initiation of therapeutic drainage to 1L	Through study completion, an average of 24 hours
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)	Immediately prior to starting the thoracentesis
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)	Through study completion, an average of 24 hours
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)	Through study completion, an average of 24 hours
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)	Immediately after removing the thoracentesis catheter
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)	5 minutes post-procedure
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)	24 hours post-procedure

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Roy Cho, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pleural effusion; thoracentesis; wall suction; manual aspiration; vacuum bottle drainage
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: PACCS-2021-30297

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No