Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study

Pleural Infection Clinical Trial

— FLAG-PINS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05702580
• Other study ID #: 0107486
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: August 2023

Study information

• Verified date: January 2023
• Source: Alexandria University
• Contact: Ahmed S Sadaka, PhD
• Phone: +201005433152
• Email: ahmad.sadaka[@]alexmed.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Pleural Infection

Intervention

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

Locations

Country	Name	City	State
Egypt	Chest Diseases Department, Alexandria University Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

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