Lung Diseasesuniportal VATSNCT03484663
Small Catheter Drainage With Chest Tube Versus Chest Tube Alone After Uniport Video-assisted Thoracoscopic Procedures
A study testing central venous catheter (small catheter drainage) in people with Lung Diseases, run by Assiut University.
Trial summary
Small catheter drainage with chest tube after uniport Video-assisted Thoracoscopic Procedures Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Diseases
- What is being tested?
- central venous catheter (small catheter drainage)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Jul 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing uniport video-assisted thoracoscopic surgery at Assiut University Hospital who need intercostal drainage postoperative
Who cannot join
- Patients who do not need intercostal tube post operative
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Small Catheter Drainage With Chest Tube After Uniport Video-assisted Thoracoscopic Procedures
Small catheter drainage with chest tube after uniport Video-assisted Thoracoscopic Procedures
Read the detailed description
Traditionally an Intercostal Tube is applied intraoperative following VATS procedures to drain the remaining pneumothorax and residual effusion , some of the residual effusion can't drain by intercostal tube which lead to prolonged hospital stay hypothesis that putting an additional small catheter drainage at the most depended part of hemithoracic early removal of chest tube without add more pain or hospital stay to the patient.
- Conditions
- Lung Diseases
- Being tested
- central venous catheter (small catheter drainage)
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous catheter (small catheter drainage)Device
Insertion central venous catheter ( small catheter drainage ) after uniport vats to decrease hospital stay and to easy drainage after procedure
| Study group | Role | What they receive |
|---|---|---|
| Small catheter with chest tube after uniport vats | Experimental | Insertion of small catheter drainage in the same opening with chest tube after uniport vats Receives: Device: central venous catheter (small catheter drainage) |
| Chest tube only after uniport vats | No intervention | After uniport vats we put chest tube only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with failure of initial intervention
Number of participants with failure of initial intervention , Requiring a second intervention i.e.insert second tube
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- case of small catheter drainage with chest tube versus chest tube alone after uniport vats
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ali mohamed abdelraouf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484663
- Sponsor's protocol ID
- uniport VATS
- Acronym
- uniportal VATS
- Status last verified
- Jun 2018
- First submitted
- 14 Mar 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Catheter Drainage With Chest Tube After Uniport Video-assisted Thoracoscopic Procedures
- ClinicalTrials.gov ID
- NCT03484663
- Acronym / sponsor ID
- uniportal VATS / uniport VATS
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 2 Apr 2018 (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.
Small catheter drainage with chest tube after uniport Video-assisted Thoracoscopic Procedures
Detailed description
Traditionally an Intercostal Tube is applied intraoperative following VATS procedures to drain the remaining pneumothorax and residual effusion , some of the residual effusion can't drain by intercostal tube which lead to prolonged hospital stay hypothesis that putting an additional small catheter drainage at the most depended part of hemithoracic early removal of chest tube without add more pain or hospital stay to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- case of small catheter drainage with chest tube versus chest tube alone after uniport vats
| Arm | Type | Receives |
|---|---|---|
| Small catheter with chest tube after uniport vats | Experimental | Device: central venous catheter (small catheter drainage)Insertion of small catheter drainage in the same opening with chest tube after uniport vats |
| Chest tube only after uniport vats | No intervention | –After uniport vats we put chest tube only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing uniport video-assisted thoracoscopic surgery at Assiut University Hospital who need intercostal drainage postoperative
Key exclusion criteria (1 listed)
- Patients who do not need intercostal tube post operative
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 |
|---|---|---|
| central venous catheter (small catheter drainage)Insertion central venous catheter ( small catheter drainage ) after uniport vats to decrease hospital stay and to easy drainage after procedure | Device | Small catheter with chest tube after uniport vats |
Primary outcome
Number of participants with failure of initial intervention
Time frame: one year
Number of participants with failure of initial intervention , Requiring a second intervention i.e.insert second tube
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing central venous catheter (small catheter drainage) in people with Lung Diseases, 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 1 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 11 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ali Abdelraouf, residant (01004396639, alioufa32@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with failure of initial intervention (time frame: one year). 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 11 Jun 2018.