Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study

NCT05702580 | Completed

• 1 other identifier: 0107486
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare the microbiologic diagnostic yield of pre-aspiration agitated pleural fluid versus that of conventionally aspirated fluid in pleural infection patients. The main question it aims to answer is, whether fluid agitation helps to increase the microbiological yield.

Conditions

Pleural Infection

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of the microbiologic analysis

  Percentage of samples with a positive microbiologic result among both aspiration techniques

  results within 1 week of sampling

Secondary Outcomes (5)

• LDH level difference between both aspiration methods

  results within 1 day of sampling

• Glucose level difference between both aspiration methods

  results within 1 day of sampling

• Protein level difference between both aspiration methods

  results within 1 day of sampling

• Neutrophilic count difference between both aspiration methods

  results within 1 day of sampling

• Lymphocytic count difference between both aspiration methods

  results within 1 day of sampling

Study Arms (1)

Standard thoracentesis followed by pre-aspiration fluid agitation

EXPERIMENTAL

Participants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique

Procedure: Agitated Pleural Fluid Thoracentesis

Interventions

Agitated Pleural Fluid Thoracentesis PROCEDURE

Using a 16-18 gauge cannula, a standard thoracentesis will be performed then a sample of pleural fluid will be aspirated and rapidly flushed into the pleural space and redrawn again for a few cycles before a sample is finally drawn into the collection syringe

Standard thoracentesis followed by pre-aspiration fluid agitation

Eligibility Criteria

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

You may qualify if:

• Age \>18 years old
• Pleural infection based on clinical presentation, imaging or laboratory investigations and pleural fluid examination showing glucose \< 40 mg/dL or pH \<7.2 with lower respiratory infection or pus on aspiration
• At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)

You may not qualify if:

• Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation
• Hemodynamic instability
• Uncorrected coagulopathy
• Transudative or exudative lymphocytic pleural effusion on biochemical analysis

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Chest Diseases Department, Alexandria University Faculty of Medicine

Alexandria, Egypt

Location

Related Publications (1)

• Sadaka A, Said R, Ashmawy H, Okasha H, Gharraf H. Pleural fluid agitation for improving the microbiologic diagnostic yield in pleural infection: a feasibility study. Respir Res. 2025 Apr 18;26(1):154. doi: 10.1186/s12931-025-03208-7.

  PMID: 40251602 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Laboratory personnel responsible for the microbiological and biochemical analysis will be blinded to the identity of the paired samples.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: All participants will undergo both thoracentesis techniques; the standard and the experimental pre-aspiration agitated fluid techniques

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 27, 2023
• Study Start: December 15, 2022
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)