Comparing Active Versus Passive Aspiration in Therapeutic Thoracentesis: Efficacy, Procedure Time… (NCT07184736) | Clinical Trial Compass
CompletedNot Applicable
Comparing Active Versus Passive Aspiration in Therapeutic Thoracentesis: Efficacy, Procedure Time, and Patient Safety
Pakistan60 participantsStarted 2020-03-01
Plain-language summary
This single-blind randomized controlled trial (RCT) aims to compare the efficacy and safety of active manual aspiration versus passive gravity drainage during therapeutic thoracentesis for large symptomatic pleural effusions. A total of 60 eligible patients will be randomized into two equal groups. The active aspiration group will undergo fluid removal using manual syringe suction, while the passive aspiration group will undergo drainage via gravity. The primary outcomes of the study are the total procedure time and the volume of pleural fluid aspirated. Secondary outcomes include patient-reported pain (measured on a Numeric Rating Scale), patient-reported dyspnea (measured by the mMRC scale), the incidence of procedure-related cough, and the reason for procedure termination. The goal of this study is to determine which technique offers a better balance of efficiency and patient comfort.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of either gender.
* Aged above 18 years.
* With symptomatic large pleural effusion (either exudative or transudative).
* Requiring therapeutic pleurocentesis.
* Modified Medical Research Council (mMRC) dyspnea scale grade 3-4.
Exclusion Criteria:
* Uncorrected bleeding diathesis.
* Chest wall cellulitis at the intended site of puncture.
* Uncooperative patients.
* Loculated pleural effusion.
* Traumatic hemothorax.
* Empyema thoracis.
* Hydropneumothorax.
* Patients who refused to participate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Volume of Fluid Aspirated
Timeframe: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
2
Procedure Time for Therapeutic Thoracentesis
Timeframe: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
Trial details
NCT IDNCT07184736
SponsorSheikh Zayed Federal Postgraduate Medical Institute