Diagnostic Yield of Agitated Exudative Non-infected Pleural Effusion

A Feasibility Study of the Diagnostic Yield of Pre-aspiration Pleural Fluid Agitation in Non-infected Pleural Effusion

The goal of this study is to compare the diagnostic yield in terms of cellular content and biochemical characteristics of pre-aspiration agitated pleural fluid versus that of conventionally aspirated fluid in pleural infection patients. The hypothesis is that the agitated fluid would be more representative and thus may aid the diagnosis of non-infected exudative pleural effusions.

Study Overview

• Status: Active, not recruiting
• Conditions: Pleural Effusion
• Intervention / Treatment: Procedure: Agitated Pleural Fluid Thoracentesis

Detailed Description

Transudation or exudation are the two mechanisms by which fluid accumulates, where Starling forces' imbalance is responsible for the former and inflammatory increase in capillary permeability accounts for the latter. Despite the history and presentation commonly suggesting the underlying etiology, pleural fluid aspiration and analysis is frequently required for confirmation of the nature and cause of the effusion. Aspirated pleural fluid is routinely subjected to biochemical analysis as well as microbiological and cytological analysis especially when infection or neoplasia is suspected. One drawback however to thoracentesis analysis is the relatively low diagnostic yield in different forms of exudative effusion. Tuberculous pleural effusions have a yield of <10% on acid-fast bacilli smears and overall yield <30% on solid culture. Conventional cytologic analysis from malignant pleural effusions also show a relatively low overall yield of around 51%, though this could be highly variable depending on the primary cancer involved (6% in mesothelioma - 80% in ovarian adenocarcinoma).In addition, it is not uncommon for analysis results to widely vary in the same patient in those with loculated and in malignant pleural effusions. This could be attributed to the compartmentalization in complex septated collections and heterogenous distribution of cellular components throughout the pleural space. The gold standard however in diagnosing unexplained exudative pleural effusions is pleural biopsy which is technically demanding and sometimes associated with longer hospital stay along with the increased incurred costs.

The investigators propose a method for improving the representativeness of pleural fluid samples via pleural agitation prior to aspiration in exudative noninfected pleural effusion. The aim is to test the feasibility and safety of using pleural fluid agitation prior to aspiration and to investigate the potential for an improved diagnostic yield using this novel thoracentesis technique in patients with exudative non-infected pleural effusion. A control group of 10 participants with transudative pleural effusion (based on history, clinical picture, and imaging) will be included to exclude any effect of the agitation procedure on the biochemical profile of the pleural fluid. These will include patients with uncontrolled heart failure, renal or hepatic impairment presenting with classical uncomplicated free pleural effusion.

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Chest Diseases Department, Alexandria University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age > 18 years old
2. 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. 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, positive gram stain or bacterial culture or pus on aspiration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard thoracentesis followed by pre-aspiration fluid agitation; Participants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield of the cytological analysis	Percentage of samples with a positive cytological result among both aspiration techniques	14 days
Diagnostic yield of the microbiolocal analysis (mycobacterial / fungal)	Percentage of samples with a evidence of mycobacterial / fungal elements among both aspiration techniques	14 days
Incidence of adverse events with pre-aspiration fluid agitation	Percentage of patients with incidence of adverse events during or right after pre-aspiration fluid agitation including pneumothorax or significant pain or cough or oxygen desaturation	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein level difference between both aspiration method	Difference in Protein levels in the aspirated fluid via both techniques	results within 1 day of sampling
Lactate dehydrogenase (LDH) level difference between both aspiration method	Difference in LDH levels in the aspirated fluid via both techniques	results within 1 day of sampling
Glusose level difference between both aspiration method	Difference in glucose levels in the aspirated fluid via both techniques	results within 1 day of sampling
Neutrophilic count difference between both aspiration method	Difference in neutrophilic count in the aspirated fluid via both techniques	results within 1 day of sampling
Lymphocytic count difference between both aspiration method	Difference in lymphocytic count in the aspirated fluid via both techniques	results within 1 day of sampling

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: pleural effusion; exudate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: 0305913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No