EmpyemaNCT06235359
Is Intercostal Tube Enough in Management of Empyema
A study testing intercostal tube in people with Empyema, run by Assiut University.
Trial summary
Is intercostal tube enough in management of empyema ? Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Empyema
- What is being tested?
- intercostal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients admitted to Assuit university Hospital and diagnosed with empyema
Who cannot join
- Patient diagnosed with Post-operative empyema
- Patient diagnosed with post traumatic empyema
- Patient diagnosed with Bronchopleural fistula
- Patient diagnosed with TB
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Is intercostal tube enough in management of empyema ?
Read the detailed description
Empyema refers to presence of pus in the pleural space -Causes Primary: bacterial Pneumonia (staph aureus, strept pneumonia , H.influenza) , TB
Secondry :
PostTraumati postoperative :open heart , esophageal, mediastinum , lung rupture of lung absess
-pathophysiology and stages During an inflammatory process such as pneumonia, there is an increase in fluid production in the pleural cavity known as the exudate stage. As the disease progresses microorganisms, usually bacteria, can colonize the fluid and generated an empyema. This fluid is characterized by elevated lactate dehydrogenase, proteins, neutrophils, and dead cells. Macroscopically is a thick opaque fluid found in the fibrinopurulent stage. After the resolution of the infection and as a consequence of the inflammation, there is a process of fibrosis that can lead to restriction of the lung parenchyma which is stage of chronic organization
- Conditions
- Empyema
- Being tested
- intercostal tube
- Medical subject headings
- Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intercostal tubeDevice
A chest tube is a hollow, flexible tube placed into the chest. It acts as a drain.
Chest tubes drain blood, fluid, or air from around your lungs, heart, or esophagus.
The tube around your lung is placed between your ribs and into the space between the inner lining and the outer lining of your chest cavity. This is called the pleural space. It allows your lungs to fully expand.
| Study group | Role | What they receive |
|---|---|---|
| intercostal tube | Other | A chest tube is a hollow, flexible tube placed into the chest. It acts as a drain.
Chest tubes drain blood, fluid, or air from around your lungs, heart, or esophagus.
The tube around your lung is placed between your ribs and into the space between the inner lining and the outer lining of your chest cavity. This is called the pleural space. It allows your lungs to fully expand. Receives: Device: intercostal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find best way to drain the pus in the pleural space
To find best way to drain the pus in the pleural space
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmpyemaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Abdelfatah mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235359
- Sponsor's protocol ID
- empyema
- Status last verified
- Jan 2024
- First submitted
- 11 Oct 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali I, Unruh H. Management of empyema thoracis. Ann Thorac Surg. 1990 Sep;50(3):355-9. doi: 10.1016/0003-4975(90)90474-k.
PubMed 2400254
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Intercostal Tube Enough in Management of Empyema
- ClinicalTrials.gov ID
- NCT06235359
- Acronym / sponsor ID
- empyema
- Conditions
- Empyema
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jan 2024 (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.
Is intercostal tube enough in management of empyema ?
Detailed description
Empyema refers to presence of pus in the pleural space -Causes Primary: bacterial Pneumonia (staph aureus, strept pneumonia , H.influenza) , TB
Secondry :
PostTraumati postoperative :open heart , esophageal, mediastinum , lung rupture of lung absess
-pathophysiology and stages During an inflammatory process such as pneumonia, there is an increase in fluid production in the pleural cavity known as the exudate stage. As the disease progresses microorganisms, usually bacteria, can colonize the fluid and generated an empyema. This fluid is characterized by elevated lactate dehydrogenase, proteins, neutrophils, and dead cells. Macroscopically is a thick opaque fluid found in the fibrinopurulent stage. After the resolution of the infection and as a consequence of the inflammation, there is a process of fibrosis that can lead to restriction of the lung parenchyma which is stage of chronic organization
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intercostal tube | Other | Device: intercostal tubeA chest tube is a hollow, flexible tube placed into the chest. It acts as a drain. Chest tubes drain blood, fluid, or air from around your lungs, heart, or esophagus. The tube around your lung is placed between your ribs and into the space between the inner lining and the outer lining of your chest cavity. This is called the pleural space. It allows your lungs to fully expand. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted to Assuit university Hospital and diagnosed with empyema
Key exclusion criteria (4 listed)
- Patient diagnosed with Post-operative empyema
- Patient diagnosed with post traumatic empyema
- Patient diagnosed with Bronchopleural fistula
- Patient diagnosed with TB
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 |
|---|---|---|
| intercostal tubeA chest tube is a hollow, flexible tube placed into the chest. It acts as a drain. Chest tubes drain blood, fluid, or air from around your lungs, heart, or esophagus. The tube around your lung is placed between your ribs and into the space between the inner lining and the outer lining of your chest cavity. This is called the pleural space. It allows your lungs to fully expand. | Device | intercostal tube |
Primary outcome
To find best way to drain the pus in the pleural space
Time frame: baseline
To find best way to drain the pus in the pleural space
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 2400254Ali I, Unruh H. Management of empyema thoracis. Ann Thorac Surg. 1990 Sep;50(3):355-9. doi: 10.1016/0003-4975(90)90474-k.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing intercostal tube in people with Empyema, run by Assiut University.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Islam abdelfatah, resident (01024984239, Islam.abdelfatah.097@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find best way to drain the pus in the pleural space (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06235359, which also lists 1 linked publication.
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 31 Jan 2024.