Comparing Active Versus Passive Aspiration in Therapeutic Thoracentesis: Efficacy, Procedure Time, and Patient Safety

NCT07184736 | Completed

• 2 other identifiers: TMahmudNo funding
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pleural Effusion

Keywords

Pleural Effusion; Thoracentesis; Active Aspiration; Passive Aspiration; Procedural Complications; Gravity Drainage; Manual Aspiration

Outcome Measures

Primary Outcomes (2)

• Volume of Fluid Aspirated

  The total volume of pleural fluid successfully removed during the procedure, measured in milliliters (ml).

  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.

  Immediately upon procedure completion (at the time of needle removal) and fluid extraction.

Secondary Outcomes (3)

• Patient-Reported Pain

  Immediately upon procedure completion (at the time of needle removal) and fluid extraction.

• Patient-Reported Dyspnea

  Immediately upon procedure completion (at the time of needle removal) and fluid extraction.

• Incidence of Cough

  Immediately upon procedure completion (at the time of needle removal) and fluid extraction.

Other Outcomes (1)

• Reason for Procedure Termination

  Immediately upon procedure completion (at the time of needle removal) and fluid extraction.

Study Arms (2)

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.

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.

Procedure: Passive Gravity Drainage

Interventions

Active Manual Syringe Aspiration PROCEDURE

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.

Active Aspiration

Passive Gravity Drainage PROCEDURE

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.

Passive Aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheikh Zayed Federal Postgraduate Medical Institute: lead

Study Sites (1)

Sheikh Zayed Hospital

Lahore, Punjab Province, 54470, Pakistan

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Talha Mahmud

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 22, 2025
• Study Start: March 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

PA (1)