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

Primary Purpose

Pleural Infection

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Agitated Pleural Fluid Thoracentesis
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation Hemodynamic instability Uncorrected coagulopathy Transudative or exudative lymphocytic pleural effusion on biochemical analysis

Sites / Locations

  • Chest Diseases Department, Alexandria University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Standard thoracentesis followed by pre-aspiration fluid agitation

Arm Description

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

Outcomes

Primary Outcome Measures

Diagnostic yield of the microbiologic analysis
Percentage of samples with a positive microbiologic result among both aspiration techniques

Secondary Outcome Measures

LDH level difference between both aspiration methods
Difference in LDH levels in the aspirated fluid via both techniques
Glucose level difference between both aspiration methods
Difference in glucose levels in the aspirated fluid via both techniques
Protein level difference between both aspiration methods
Difference in protein levels in the aspirated fluid via both techniques
Neutrophilic count difference between both aspiration methods
Difference in neutrophilic count in the aspirated fluid via both techniques
Lymphocytic count difference between both aspiration methods
Difference in lymphocytic count in the aspirated fluid via both techniques

Full Information

First Posted
December 23, 2022
Last Updated
January 26, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05702580
Brief Title
Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study
Acronym
FLAG-PINS
Official Title
Pleural Fluid Agitation For Improving The Microbiologic Diagnostic Yield In Pleural Infection - A Comparative Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will undergo both thoracentesis techniques; the standard and the experimental pre-aspiration agitated fluid techniques
Masking
None (Open Label)
Masking Description
Laboratory personnel responsible for the microbiological and biochemical analysis will be blinded to the identity of the paired samples.
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard thoracentesis followed by pre-aspiration fluid agitation
Arm Type
Experimental
Arm Description
Participants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique
Intervention Type
Procedure
Intervention Name(s)
Agitated Pleural Fluid Thoracentesis
Intervention Description
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
Primary Outcome Measure Information:
Title
Diagnostic yield of the microbiologic analysis
Description
Percentage of samples with a positive microbiologic result among both aspiration techniques
Time Frame
results within 1 week of sampling
Secondary Outcome Measure Information:
Title
LDH level difference between both aspiration methods
Description
Difference in LDH levels in the aspirated fluid via both techniques
Time Frame
results within 1 day of sampling
Title
Glucose level difference between both aspiration methods
Description
Difference in glucose levels in the aspirated fluid via both techniques
Time Frame
results within 1 day of sampling
Title
Protein level difference between both aspiration methods
Description
Difference in protein levels in the aspirated fluid via both techniques
Time Frame
results within 1 day of sampling
Title
Neutrophilic count difference between both aspiration methods
Description
Difference in neutrophilic count in the aspirated fluid via both techniques
Time Frame
results within 1 day of sampling
Title
Lymphocytic count difference between both aspiration methods
Description
Difference in lymphocytic count in the aspirated fluid via both techniques
Time Frame
results within 1 day of sampling

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation Hemodynamic instability Uncorrected coagulopathy Transudative or exudative lymphocytic pleural effusion on biochemical analysis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed S Sadaka, PhD
Phone
+201005433152
Email
ahmad.sadaka@alexmed.edu.eg
Facility Information:
Facility Name
Chest Diseases Department, Alexandria University Faculty of Medicine
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed S Sadaka, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study

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