Thoracentesis QI Study

Pleural Effusion Clinical Trial

Official title:

Thoracentesis Quality Improvement (QI) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05424120
• Other study ID #: PACCS-2021-30297
• Status: Completed
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Procedure:
• Manual aspiration
One option from standard of care
• Wall suction
One option from standard of care
• Vacuum bottle drainage
One option from standard of care

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural time to 500mL	Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL	Through study completion, an average of 24 hours
Primary	Procedural time to 750mL	Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL	Through study completion, an average of 24 hours
Primary	Procedural time to 1L	Time to pleural fluid drainage from initiation of therapeutic drainage to 1L	Through study completion, an average of 24 hours
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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