Clinical trial NCT05702580: Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study
Official title: Pleural Fluid Agitation For Improving The Microbiologic Diagnostic Yield In Pleural Infection - A Comparative Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Infection
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will undergo both thoracentesis techniques; the standard and the experimental pre-aspiration agitated fluid techniques
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield of the microbiologic analysis
timeFrame: results within 1 week of sampling
Secondary outcomes:
measure: LDH level difference between both aspiration methods
timeFrame: results within 1 day of sampling
measure: Glucose level difference between both aspiration methods
timeFrame: results within 1 day of sampling
measure: Protein level difference between both aspiration methods
timeFrame: results within 1 day of sampling
measure: Neutrophilic count difference between both aspiration methods
timeFrame: results within 1 day of sampling
measure: Lymphocytic count difference between both aspiration methods
timeFrame: results within 1 day of sampling
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Chest Diseases Department, Alexandria University Faculty of Medicine
Study officials:
References: