Skip to main content
OpenTrials
Completed

NCT Number: NCT07184736

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pleural Effusion Pleural Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Hospital

Lahore, Punjab Province, 54470, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Patient-Reported Pain

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

    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).

  2. Patient-Reported Dyspnea

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

    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.

  3. Incidence of Cough

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

    The occurrence of cough during or at the end of the procedure, recorded as a binary outcome (yes/no).

Other outcomes

  1. Reason for Procedure Termination

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

    The specific reason for stopping the procedure, categorized as: (1) target fluid volume (1-1.5L) achieved, or (2) terminated early due to complications (e.g., cough, chest discomfort) or spontaneous drainage cessation.

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Federal Postgraduate Medical Institute

Other

Registry information

Acronym: Thoracentesis

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.