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

S

Sheikh Zayed Federal Postgraduate Medical Institute

Status

Completed

Conditions

Pleural Effusion

Treatments

Procedure: Active Manual Syringe Aspiration
Procedure: Passive Gravity Drainage

Study type

Interventional

Funder types

Other

Identifiers

NCT07184736
No funding
TMahmud

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Active Aspiration
Experimental group
Description:
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.
Treatment:
Procedure: Active Manual Syringe Aspiration
Passive Aspiration
Experimental group
Description:
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.
Treatment:
Procedure: Passive Gravity Drainage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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