Diagnostic Yield of Agitated Exudative Non-infected Pleural Effusion

NCT05819294 | Unknown

• 1 other identifier: 0305913
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pleural Effusion

Keywords

pleural effusion; exudate

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Protein level difference between both aspiration method

  results within 1 day of sampling

• Lactate dehydrogenase (LDH) level difference between both aspiration method

  results within 1 day of sampling

• Glusose level difference between both aspiration method

  results within 1 day of sampling

• Neutrophilic count difference between both aspiration method

  results within 1 day of sampling

• Lymphocytic count difference between both aspiration method

  results within 1 day of sampling

Study Arms (1)

Standard thoracentesis followed by pre-aspiration fluid agitation

EXPERIMENTAL

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

Procedure: Agitated Pleural Fluid Thoracentesis

Interventions

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

Standard thoracentesis followed by pre-aspiration fluid agitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)

You may not qualify if:

• Minimal - mild pleural fluid deemed unsuitable for aspiration and agitation
• Hemodynamic instability
• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Chest Diseases Department, Alexandria University Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Laboratory personnel responsible for the cytological and biochemical analysis will be blinded to the identity of the paired samples
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: April 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)