Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study

Not Applicable

Completed

• Conditions: Pleural Infection
• Interventions: Procedure: Agitated Pleural Fluid Thoracentesis

• Registration Number: NCT05702580
• Lead Sponsor: Alexandria University

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.

Detailed Description

In pleural infection, It is suggested that the bacteria being diagnostically targeted, might more likely be residing on the pleural surface with a better blood supply and nutrition rather than being planktonic in the acidic, glucose deficient pleural fluid. The investigators thus hypothesize that an agitation of the pleural fluid prior to sample aspiration would aid in achieving a better cellular representation of the pleural space. This could have the effect of washing bacterial cells off the pleural surface as well as moving sedimented cells in the aspirated sample. This study aims to investigate whether an increase in the microbiological yield for infected pleural fluid could be achieved by a pre-aspiration agitation of the pleural fluid which would have a positive effect on management and eventual patient outcomes. Adult participants with pleural infection will undergo thoracentesis via both the standard and agitated fluid techniques guided by thoracic ultrasound. Microbiological yields will be compared.

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-27
• Primary Completion: 2024-01-29
• Study Completion: 2024-01-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-20
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Age >18 years old
2. 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
3. At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)

Exclusion Criteria

1. Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation
2. Hemodynamic instability
3. Uncorrected coagulopathy
4. Transudative or exudative lymphocytic pleural effusion on biochemical analysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard thoracentesis followed by pre-aspiration fluid agitation	Agitated Pleural Fluid Thoracentesis	Participants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of the microbiologic analysis	results within 1 week of sampling	Percentage of samples with a positive microbiologic result among both aspiration techniques

Secondary Outcome Measures

Name	Time	Method
Protein level difference between both aspiration methods	results within 1 day of sampling	Difference in protein levels in the aspirated fluid via both techniques
Neutrophilic count difference between both aspiration methods	results within 1 day of sampling	Difference in neutrophilic count in the aspirated fluid via both techniques
Glucose level difference between both aspiration methods	results within 1 day of sampling	Difference in glucose levels in the aspirated fluid via both techniques
LDH level difference between both aspiration methods	results within 1 day of sampling	Difference in LDH levels in the aspirated fluid via both techniques
Lymphocytic count difference between both aspiration methods	results within 1 day of sampling	Difference in lymphocytic count in the aspirated fluid via both techniques

Trial Locations

Locations (1)

Chest Diseases Department, Alexandria University Faculty of Medicine; 🇪🇬 Alexandria, Egypt