Thoracentesis QI Study

Study Overview
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Brief Summary
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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.

Official Title
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Thoracentesis Quality Improvement (QI) Study

Conditions
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Pleural Effusion

Intervention / Treatment
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* Procedure: Manual aspiration
* Procedure: Wall suction
* Procedure: Vacuum bottle drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pleural effusion, thoracentesis, wall suction, manual aspiration, vacuum bottle drainage