Pleural EffusionNCT05424120
Thoracentesis QI Study
A study testing Manual aspiration, Wall suction and Vacuum bottle drainage in people with Pleural Effusion, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Manual aspiration, Wall suction and Vacuum bottle drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Evidence of pleural effusion on imaging
- Clinical indication for thoracentesis
Who cannot join
- Age <18
- Standard contraindication for thoracentesis procedure
- Patients on positive pressure ventilation
- Patients who have opted out of research in EPIC
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Thoracentesis Quality Improvement (QI) Study
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
- Being tested
- Manual aspiration, Wall suction, Vacuum bottle drainage
- Keywords
- pleural effusion, thoracentesis, wall suction, manual aspiration, vacuum bottle drainage
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual aspirationProcedure or surgery
One option from standard of care
Wall suctionProcedure or surgery
One option from standard of care
Vacuum bottle drainageProcedure or surgery
One option from standard of care
| Study group | Role | What they receive |
|---|---|---|
| Manual aspiration | Active comparator | pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock Receives: 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 Receives: 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 Receives: Procedure: Vacuum bottle drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural time to 500mL
Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL
Measured: Through study completion, an average of 24 hours
Procedural time to 750mL
Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL
Measured: Through study completion, an average of 24 hours
Procedural time to 1L
Time to pleural fluid drainage from initiation of therapeutic drainage to 1L
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start18 Jan 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roy Cho, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424120
- Sponsor's protocol ID
- PACCS-2021-30297
- Status last verified
- Nov 2023
- First submitted
- 25 Apr 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracentesis Quality Improvement (QI) Study
- ClinicalTrials.gov ID
- NCT05424120
- Acronym / sponsor ID
- PACCS-2021-30297
- Conditions
- Pleural Effusion
- Keywords
- pleural effusion, thoracentesis, wall suction, manual aspiration, vacuum bottle drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Manual aspiration | Active comparator | Procedure: Manual aspirationpleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock |
| Wall suction | Active comparator | Procedure: Wall suctionpleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously |
| Vacuum bottle drainage | Active comparator | Procedure: Vacuum bottle drainagepleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18
- Evidence of pleural effusion on imaging
- Clinical indication for thoracentesis
Key exclusion criteria (4 listed)
- Age <18
- Standard contraindication for thoracentesis procedure
- Patients on positive pressure ventilation
- Patients who have opted out of research in EPIC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual aspirationOne option from standard of care | Procedure or surgery | Manual aspiration |
| Wall suctionOne option from standard of care | Procedure or surgery | Wall suction |
| Vacuum bottle drainageOne option from standard of care | Procedure or surgery | Vacuum bottle drainage |
Primary outcome
Procedural time to 500mL
Time frame: Through study completion, an average of 24 hours
Time to pleural fluid drainage from initiation of therapeutic drainage to 500mL
Procedural time to 750mL
Time frame: Through study completion, an average of 24 hours
Time to pleural fluid drainage from initiation of therapeutic drainage to 750mL
Procedural time to 1L
Time frame: Through study completion, an average of 24 hours
Time to pleural fluid drainage from initiation of therapeutic drainage to 1L
Pain and dyspnea scores- Baseline
Time frame: 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
Time frame: 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-fluid
Time frame: 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
Time frame: 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)
Pain and dyspnea scores- 5m post
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Cho, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual aspiration, Wall suction and Vacuum bottle drainage in people with Pleural Effusion, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural time to 500mL (time frame: Through study completion, an average of 24 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.