Fluid Agitation Microbiologic Yield In Pleural Infection Feasibility Study

NCT ID: NCT05702580

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-01-29

Brief Summary

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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

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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.

Conditions

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Pleural Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

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

Study Groups

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Standard thoracentesis followed by pre-aspiration fluid agitation

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

Group Type EXPERIMENTAL

Agitated Pleural Fluid Thoracentesis

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Salama Sadaka

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chest Diseases Department, Alexandria University Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Sadaka A, Said R, Ashmawy H, Okasha H, Gharraf H. Pleural fluid agitation for improving the microbiologic diagnostic yield in pleural infection: a feasibility study. Respir Res. 2025 Apr 18;26(1):154. doi: 10.1186/s12931-025-03208-7.

Reference Type DERIVED
PMID: 40251602 (View on PubMed)

Other Identifiers

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0107486

Identifier Type: -

Identifier Source: org_study_id

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