Pleural EffusionNCT05819294
Diagnostic Yield of Agitated Exudative Non-infected Pleural Effusion
A study testing Agitated Pleural Fluid Thoracentesis in people with Pleural Effusion, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Agitated Pleural Fluid Thoracentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Chest Diseases Department, Alexandria University Faculty of Medicine
Alexandria
About this study
Official title: 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.
Read the 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.
- Conditions
- Pleural Effusion
- Being tested
- Agitated Pleural Fluid Thoracentesis
- Keywords
- pleural effusion, exudate
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agitated Pleural Fluid ThoracentesisProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Standard thoracentesis followed by pre-aspiration fluid agitation | Experimental | Participants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique Receives: Procedure: Agitated Pleural Fluid Thoracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield of the cytological analysis
Percentage of samples with a positive cytological result among both aspiration techniques
Measured: 14 days
Diagnostic yield of the microbiolocal analysis (mycobacterial / fungal)
Percentage of samples with a evidence of mycobacterial / fungal elements among both aspiration techniques
Measured: 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
Measured: 14 days
Secondary outcomes (5)
Protein level difference between both aspiration method
Difference in Protein levels in the aspirated fluid via both techniques
Measured: 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
Measured: results within 1 day of sampling
Glusose level difference between both aspiration method
Difference in glucose levels in the aspirated fluid via both techniques
Measured: results within 1 day of sampling
Neutrophilic count difference between both aspiration method
Difference in neutrophilic count in the aspirated fluid via both techniques
Measured: results within 1 day of sampling
Lymphocytic count difference between both aspiration method
Difference in lymphocytic count in the aspirated fluid via both techniques
Measured: results within 1 day of sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Apr 2023
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo both thoracentesis techniques; the standard and the experimental pre-aspiration agitated fluid techniques
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salama Sadaka, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819294
- Sponsor's protocol ID
- 0305913
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of the Diagnostic Yield of Pre-aspiration Pleural Fluid Agitation in Non-infected Pleural Effusion
- ClinicalTrials.gov ID
- NCT05819294
- Acronym / sponsor ID
- 0305913
- Conditions
- Pleural Effusion
- Keywords
- pleural effusion, exudate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo both thoracentesis techniques; the standard and the experimental pre-aspiration agitated fluid techniques
| Arm | Type | Receives |
|---|---|---|
| Standard thoracentesis followed by pre-aspiration fluid agitation | Experimental | Procedure: Agitated Pleural Fluid ThoracentesisParticipants will undergo the standard thoracentesis followed by the experimental pre-aspiration fluid agitation technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years old
- At least a moderate amount of pleural fluid collection (2 or more intercostal spaces on thoracic ultrasound)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agitated Pleural Fluid ThoracentesisUsing 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 | Procedure or surgery | Standard thoracentesis followed by pre-aspiration fluid agitation |
Primary outcome
Diagnostic yield of the cytological analysis
Time frame: 14 days
Percentage of samples with a positive cytological result among both aspiration techniques
Diagnostic yield of the microbiolocal analysis (mycobacterial / fungal)
Time frame: 14 days
Percentage of samples with a evidence of mycobacterial / fungal elements among both aspiration techniques
Incidence of adverse events with pre-aspiration fluid agitation
Time frame: 14 days
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
5 secondary outcomes
Protein level difference between both aspiration method
Time frame: results within 1 day of sampling
Lactate dehydrogenase (LDH) level difference between both aspiration method
Time frame: results within 1 day of sampling
Glusose level difference between both aspiration method
Time frame: results within 1 day of sampling
Neutrophilic count difference between both aspiration method
Time frame: results within 1 day of sampling
Lymphocytic count difference between both aspiration method
Time frame: results within 1 day of sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Agitated Pleural Fluid Thoracentesis in people with Pleural Effusion, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of the cytological analysis (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.