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

Not Applicable

Completed

• Conditions: Pleural Effusion

• Registration Number: NCT07184736
• Lead Sponsor: Sheikh Zayed Federal Postgraduate Medical Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-13
• Last Update Submitted: 2025-09-13
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Volume of Fluid Aspirated	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	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 Outcome Measures

Name	Time	Method
Patient-Reported Pain	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).
Patient-Reported Dyspnea	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.
Incidence of Cough	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).

Trial Locations

Locations (1)

Sheikh Zayed Hospital; 🇵🇰 Lahore, Punjab Province, Pakistan