Thoracentesis QI Study

• Sponsor: University of Minnesota (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05424120
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 17.3
• Patients Per Site Per Month: 5.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pleural Effusion	Procedure: Manual aspiration; Procedure: Wall suction; Procedure: Vacuum bottle drainage	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Thoracentesis Quality Improvement (QI) Study
• Actual Study Start Date: Jan 18, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Procedural time to 500mL [Through study completion, an average of 24 hours]

   Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL

2. Procedural time to 750mL [Through study completion, an average of 24 hours]

   Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL

3. Procedural time to 1L [Through study completion, an average of 24 hours]

   Time to pleural fluid drainage from initiation of therapeutic drainage to 1L

4. Pain and dyspnea scores- Baseline [Immediately prior to starting the thoracentesis]

   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. Pain and dyspnea scores- Cath [Through study completion, an average of 24 hours]

   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)

6. Pain and dyspnea scores- Post-fluid [Through study completion, an average of 24 hours]

   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)

7. Pain and dyspnea scores- Post-cath [Immediately after removing the thoracentesis catheter]

   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)

8. Pain and dyspnea scores- 5m post [5 minutes post-procedure]

   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)

9. Pain and dyspnea scores- 24h post [24 hours post-procedure]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT05424120
• Other Study ID Numbers: PACCS-2021-30297
• First Posted: Jun 21, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Minnesota: pleural effusion; thoracentesis; wall suction; manual aspiration; vacuum bottle drainage
• Additional relevant MeSH terms: Pleural Effusion

Study Results

No Results Posted as of Jun 21, 2022