Thoracentesis QI Study

NCT05424120 | Completed DMC

• 1 other identifier: PACCS-2021-30297
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion

Keywords

pleural effusion; thoracentesis; wall suction; manual aspiration; vacuum bottle drainage

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (3)

Manual aspiration

ACTIVE COMPARATOR

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

Procedure: Manual aspiration

Wall suction

ACTIVE COMPARATOR

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

Procedure: Wall suction

Vacuum bottle drainage

ACTIVE COMPARATOR

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

Procedure: Vacuum bottle drainage

Interventions

Manual aspiration PROCEDURE

One option from standard of care

Manual aspiration

Wall suction PROCEDURE

One option from standard of care

Wall suction

Vacuum bottle drainage PROCEDURE

One option from standard of care

Vacuum bottle drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Roy Cho, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: June 21, 2022
• Study Start: January 18, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

US (1)