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Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05702580
Acronym
FLAG-PINS
Enrollment
30
Registered
2023-01-27
Start date
2022-12-15
Completion date
2024-01-29
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Infection

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.

Interventions

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Laboratory personnel responsible for the microbiological and biochemical analysis will be blinded to the identity of the paired samples.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic yield of the microbiologic analysisresults within 1 week of samplingPercentage of samples with a positive microbiologic result among both aspiration techniques

Secondary

MeasureTime frameDescription
LDH level difference between both aspiration methodsresults within 1 day of samplingDifference in LDH levels in the aspirated fluid via both techniques
Glucose level difference between both aspiration methodsresults within 1 day of samplingDifference in glucose levels in the aspirated fluid via both techniques
Protein level difference between both aspiration methodsresults within 1 day of samplingDifference in protein levels in the aspirated fluid via both techniques
Neutrophilic count difference between both aspiration methodsresults within 1 day of samplingDifference in neutrophilic count in the aspirated fluid via both techniques
Lymphocytic count difference between both aspiration methodsresults within 1 day of samplingDifference in lymphocytic count in the aspirated fluid via both techniques

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026