Thoracentesis QI Study

Not Applicable

Completed

• Conditions: Pleural Effusion
• Interventions: Procedure: Vacuum bottle drainage; Procedure: Manual aspiration; Procedure: Wall suction

• Registration Number: NCT05424120
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vacuum bottle drainage	Vacuum bottle drainage	pleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container
Manual aspiration	Manual aspiration	pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock
Wall suction	Wall suction	pleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously

Primary Outcome Measures

Name	Time	Method
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)
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)
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)
Procedural time to 500mL	Through study completion, an average of 24 hours	Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL
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)
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)
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)
Procedural time to 750mL	Through study completion, an average of 24 hours	Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL
Procedural time to 1L	Through study completion, an average of 24 hours	Time to pleural fluid drainage from initiation of therapeutic drainage to 1L

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States