Pleural EffusionThoracentesisNCT07184736
Comparing Active Versus Passive Aspiration in Therapeutic Thoracentesis: Efficacy, Procedure Time, and Patient Safety
A study testing Active Manual Syringe Aspiration and Passive Gravity Drainage in people with Pleural Effusion, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
Trial 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. 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?
- Active Manual Syringe Aspiration and Passive Gravity Drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2020to 1 Mar 2022
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pleural Effusion
- Being tested
- Active Manual Syringe Aspiration, Passive Gravity Drainage
- Keywords
- Pleural Effusion, Thoracentesis, Active Aspiration, Passive Aspiration, Procedural Complications, Gravity Drainage, Manual Aspiration
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Manual Syringe AspirationProcedure or surgery
For the Active Manual Syringe Aspiration, the operator manually withdraws pleural fluid using a syringe attached to a 3-way stopcock and transfusion set. The fluid is then expelled into a collection bag.
Passive Gravity DrainageProcedure or surgery
In Passive Gravity Drainage, after confirming proper needle placement with initial aspiration, the syringe is detached, and pleural fluid is allowed to drain passively by gravity through the transfusion set into a collection bag.
| Study group | Role | What they receive |
|---|---|---|
| Active Aspiration | Experimental | For the Active Aspiration Group (n=30), fluid was actively aspirated using a syringe and expelled into a collection bag via a 3-way stopcock. Receives: Procedure: Active Manual Syringe Aspiration |
| Passive Aspiration | Experimental | In the passive Aspiration Group (n=30), after initial aspiration to confirm needle placement, the syringe was removed, and fluid was allowed to drain passively via gravity into the collection bag. Receives: Procedure: Passive Gravity Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Fluid Aspirated
The total volume of pleural fluid successfully removed during the procedure, measured in milliliters (ml).
Measured: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
Procedure Time for Therapeutic Thoracentesis
The total duration of the thoracentesis procedure, measured in minutes, from the initial needle insertion until the procedure was terminated. Termination occurred when no more fluid could be drained, the target volume was reached, or due to patient complications like cough or discomfort.
Measured: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
Secondary outcomes (3)
Patient-Reported Pain
The level of pain experienced by the patient during or immediately after the procedure, measured using the Numeric Rating Scale (NRS-11), an 11-point scale from 0 (no pain) to 10 (worst pain imaginable).
Measured: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
Patient-Reported Dyspnea
Description: The level of shortness of breath (dyspnea) was measured using the modified Medical Research Council (mMRC) Dyspnea Scale. The mMRC scale is a 5-point grade-based scale (Range: 0 to 4) used to categorize the severity of a patient's disability due to breathlessness. A higher score indicates a worse outcome.
Grade 0: No breathlessness except with strenuous exercise. Grade 1: Shortness of breath when hurrying on level ground or walking up a slight hill.
Grade 2: Walks slower than people of the same age on level ground because of breathlessness, or has to stop for breath when walking at own pace on level ground.
Grade 3: Stops for breath after walking about 100 meters or after a few minutes on level ground.
Grade 4: Too breathless to leave the house, or breathless when dressing or undressing.
Measured: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
Incidence of Cough
The occurrence of cough during or at the end of the procedure, recorded as a binary outcome (yes/no).
Measured: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Mar 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talha Mahmud, Sheikh Zayed Federal Postgraduate Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184736
- Sponsor's protocol ID
- TMahmud
- Other IDs
- No funding
- Acronym
- Thoracentesis
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Active Versus Passive Aspiration in Therapeutic Thoracentesis: Efficacy, Procedure Time, and Patient Safety
- ClinicalTrials.gov ID
- NCT07184736
- Acronym / sponsor ID
- Thoracentesis / TMahmud
- Conditions
- Pleural Effusion
- Keywords
- Pleural Effusion, Thoracentesis, Active Aspiration, Passive Aspiration, Procedural Complications, Gravity Drainage, Manual Aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheikh Zayed Federal Postgraduate Medical InstituteUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 22 Sep 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Aspiration | Experimental | Procedure: Active Manual Syringe AspirationFor the Active Aspiration Group (n=30), fluid was actively aspirated using a syringe and expelled into a collection bag via a 3-way stopcock. |
| Passive Aspiration | Experimental | Procedure: Passive Gravity DrainageIn the passive Aspiration Group (n=30), after initial aspiration to confirm needle placement, the syringe was removed, and fluid was allowed to drain passively via gravity into the collection bag. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Uncorrected bleeding diathesis.
- Chest wall cellulitis at the intended site of puncture.
- Uncooperative patients.
- Loculated pleural effusion.
- Traumatic hemothorax.
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 |
|---|---|---|
| Active Manual Syringe AspirationFor the Active Manual Syringe Aspiration, the operator manually withdraws pleural fluid using a syringe attached to a 3-way stopcock and transfusion set. The fluid is then expelled into a collection bag. | Procedure or surgery | Active Aspiration |
| Passive Gravity DrainageIn Passive Gravity Drainage, after confirming proper needle placement with initial aspiration, the syringe is detached, and pleural fluid is allowed to drain passively by gravity through the transfusion set into a collection bag. | Procedure or surgery | Passive Aspiration |
Primary outcome
Volume of Fluid Aspirated
Time frame: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
The total volume of pleural fluid successfully removed during the procedure, measured in milliliters (ml).
Procedure Time for Therapeutic Thoracentesis
Time frame: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
The total duration of the thoracentesis procedure, measured in minutes, from the initial needle insertion until the procedure was terminated. Termination occurred when no more fluid could be drained, the target volume was reached, or due to patient complications like cough or discomfort.
3 secondary outcomes
Patient-Reported Pain
Time frame: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
Patient-Reported Dyspnea
Time frame: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
Incidence of Cough
Time frame: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.
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 22 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Manual Syringe Aspiration and Passive Gravity Drainage in people with Pleural Effusion, run by Sheikh Zayed Federal Postgraduate Medical Institute at 1 site in Pakistan.
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 5 inclusion and 8 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 22 Sep 2025. 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 Pakistan. 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?
Volume of Fluid Aspirated (time frame: Immediately upon procedure completion (at the time of needle removal) and fluid extraction.). The study lists 2 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 22 Sep 2025.