Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study (FLAG-PINS)

Pleural Fluid Agitation For Improving The Microbiologic Diagnostic Yield In Pleural Infection - A Comparative Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pleural Infection
• Intervention / Treatment: Procedure: Agitated Pleural Fluid Thoracentesis

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed S Sadaka, PhD; Phone Number: +201005433152; Email: ahmad.sadaka@alexmed.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Chest Diseases Department, Alexandria University Faculty of Medicine
    • Contact: Ahmed S Sadaka, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard thoracentesis followed by pre-aspiration fluid agitation; Participants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique	Procedure: Agitated Pleural Fluid Thoracentesis; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 0107486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No