Pleural EffusionpigtailNCT05641779
Pigtail Catheter for Drainage of (Pneumothorax/Simple Effusion) is a Effective Procedure
An observational study of Pleural Effusion, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment and evaluation of Pigtail application in drainage of pneumothorax and haemothorax. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- pigtail
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2022to May 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patient full filing my inclusion criteria participate in my study
Who may be able to join
- iatrogenic pneumothorax
Who cannot join
- Age less than 18 years.
- refused to participate.
- Unconscious.
- spontaneous pneumothorax.
Trial locations and contacts
1 site in 1 country.
About this study
Assessment and evaluation of Pigtail application in drainage of pneumothorax and haemothorax.
Read the detailed description
Chest injuries are common following blunt and penetrating trauma. Fewer than 10 per cent of blunt injuries and 15-30 per cent of penetrating injuries require surgical management1. Most can be managed with tube thoracostomy to expand the lung (pneumothorax) or to drain blood (haemothorax)2. Although tube thoracostomy is fairly effective, it can be associated with complications such as mispositioning, malfunction, or injury by insertion through the diaphragm or liver3-5. The standard tube size.
Has usuallybeen32-40Fr.Insertion of such a large -calibre tube requires a cut-down technique, can be traumatic, and is often associated with significant pain and discomfort. Pigtail catheters, originally used by cardiologists to drain chronic pericardial effusion6, were later modified and adapted for pleural drainage7. Because of their small size and reduced trauma during placement, patients may experience significantly decreased pain and discomfort. Pigtail catheters are frequently used in the paediatric population8-10, as well as in adult, non-traumatic situations11-17 Pigtail catheters inserted at the bedside have similar efficacy to traditional chest tube.
- Conditions
- Pleural Effusion
- Being tested
- pigtail
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pigtailDevice
pigtail catheter insertion in chest in the pleural cavity
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective drainage of pleural effusion and pneumothorax
Effective drainage of pleural effusion and pneumothorax by using the imaging Rhea's method . techniques (chest x-ray and ultrasound ) By measuring the pneumothorax rim and pleural effusion in centimeters . Sum of interpleural distance Read pneumothorax size from table PA and AP .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2025 (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 Pleural EffusionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed gamal gaber, Assiut University
- Investigators
- ali a wahab, profesor, Study director, Assiut Universitymahmoud h elnaby, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641779
- Sponsor's protocol ID
- pigtail drainage
- Acronym
- pigtail
- Status last verified
- Nov 2022
- First submitted
- 17 Apr 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang SH, Kang YN, Chiu HY, Chiu YH. A Systematic Review and Meta-Analysis Comparing Pigtail Catheter and Chest Tube as the Initial Treatment for Pneumothorax. Chest. 2018 May;153(5):1201-1212. doi: 10.1016/j.chest.2018.01.048. Epub 2018 Feb 13.
PubMed 29452099
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pigtail Catheter for Drainage of (Pneumothorax/Simple Effusion) is a Effective Procedure
- ClinicalTrials.gov ID
- NCT05641779
- Acronym / sponsor ID
- pigtail / pigtail drainage
- Conditions
- Pleural Effusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 8 Dec 2022 (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.
Assessment and evaluation of Pigtail application in drainage of pneumothorax and haemothorax.
Detailed description
Chest injuries are common following blunt and penetrating trauma. Fewer than 10 per cent of blunt injuries and 15-30 per cent of penetrating injuries require surgical management1. Most can be managed with tube thoracostomy to expand the lung (pneumothorax) or to drain blood (haemothorax)2. Although tube thoracostomy is fairly effective, it can be associated with complications such as mispositioning, malfunction, or injury by insertion through the diaphragm or liver3-5. The standard tube size.
Has usuallybeen32-40Fr.Insertion of such a large -calibre tube requires a cut-down technique, can be traumatic, and is often associated with significant pain and discomfort. Pigtail catheters, originally used by cardiologists to drain chronic pericardial effusion6, were later modified and adapted for pleural drainage7. Because of their small size and reduced trauma during placement, patients may experience significantly decreased pain and discomfort. Pigtail catheters are frequently used in the paediatric population8-10, as well as in adult, non-traumatic situations11-17 Pigtail catheters inserted at the bedside have similar efficacy to traditional chest tube.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patient full filing my inclusion criteria participate in my study
Key inclusion criteria (1 listed)
- iatrogenic pneumothorax
Key exclusion criteria (4 listed)
- Age less than 18 years.
- refused to participate.
- Unconscious.
- spontaneous pneumothorax.
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 |
|---|---|---|
| pigtailpigtail catheter insertion in chest in the pleural cavity | Device | – |
Primary outcome
Effective drainage of pleural effusion and pneumothorax
Time frame: baseline
Effective drainage of pleural effusion and pneumothorax by using the imaging Rhea's method . techniques (chest x-ray and ultrasound ) By measuring the pneumothorax rim and pleural effusion in centimeters . Sum of interpleural distance Read pneumothorax size from table PA and AP .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Results publication: PubMed 29452099Chang SH, Kang YN, Chiu HY, Chiu YH. A Systematic Review and Meta-Analysis Comparing Pigtail Catheter and Chest Tube as the Initial Treatment for Pneumothorax. Chest. 2018 May;153(5):1201-1212. doi: 10.1016/j.chest.2018.01.048. Epub 2018 Feb 13.
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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.
ali a wahab, profesor study director
Assiut University
mahmoud h elnaby, lecturer study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 8 Dec 2022. 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?
Contact mohamed g gaber, resident (01067930733, mohamedgamalsweed4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective drainage of pleural effusion and pneumothorax (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 NCT05641779, 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 8 Dec 2022.