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Completed

NCT Number: NCT05702580

Fluid Agitation Microbiologic Yield In Pleural Infection 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chest Diseases Department, Alexandria University Faculty of Medicine

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Agitated Pleural Fluid Thoracentesis

Procedure

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 outcomes

  1. Diagnostic yield of the microbiologic analysis

    Time frame: results within 1 week of sampling

    Percentage of samples with a positive microbiologic result among both aspiration techniques

Secondary outcomes

  1. LDH level difference between both aspiration methods

    Time frame: results within 1 day of sampling

    Difference in LDH levels in the aspirated fluid via both techniques

  2. Glucose level difference between both aspiration methods

    Time frame: results within 1 day of sampling

    Difference in glucose levels in the aspirated fluid via both techniques

  3. Protein level difference between both aspiration methods

    Time frame: results within 1 day of sampling

    Difference in protein levels in the aspirated fluid via both techniques

  4. Neutrophilic count difference between both aspiration methods

    Time frame: results within 1 day of sampling

    Difference in neutrophilic count in the aspirated fluid via both techniques

  5. Lymphocytic count difference between both aspiration methods

    Time frame: results within 1 day of sampling

    Difference in lymphocytic count in the aspirated fluid via both techniques

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: FLAG-PINS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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