Pneumothorax and Air LeakNCT05230420
Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries
A study testing Clamping and Urine bag in people with Pneumothorax and Air Leak and Pneumothorax, run by Al-Quds University at 4 sites in 3 countries.
Trial summary
Investigators will compare two different approaches of postoperative drainage after the standard water-seal drain has been used efficiently; one is by using urine bag and check it get blown by the leaked air, two is by using clamping of the water seal drain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax and Air Leak, Pneumothorax, Pleura Injury
- What is being tested?
- Clamping and Urine bag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Jan 2022to 25 Dec 2022
- 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
- post lung resection patients (via Uniportal VATS only)
- Over the age of 18
- indicated chest tube
Who cannot join
- Under the age of 18
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Egypt2 sites, 2 recruiting
- Not yet recruiting
Assiut University
Asyut
Hussein Elkhayat, MD, dr_khayat@hotmail.com
- Not yet recruiting
Tanta University
Tanta
Ahmed Elkholy, MD, ahmed.elkholy@med.tanta.edu.eg
Italy1 site, 1 recruiting
- Not yet recruiting
European Institute of Oncology
Milan
Luca Bertolaccini, MD, luca.bertolaccini@gmail.com
Palestinian Territories1 site, 1 recruiting
- Recruiting
Makassed Hospital
East Jerusalem
Rami Alaraj, MD Candidate, 0598488897 ext. 970, ra.alaraj@gmail.com
About this study
Investigators will compare two different approaches of postoperative drainage after the standard water-seal drain has been used efficiently; one is by using urine bag and check it get blown by the leaked air, two is by using clamping of the water seal drain. Investigators will compare them depending on several factors such as; cost effectiveness, hospital stay, duration of putting the drain and more, reinsertion of the chest tube and others.
- Being tested
- Clamping, Urine bag
- Medical subject headings
- Pneumothorax, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClampingOther
Clamping of chest tube
Urine bagOther
Attachment of a urine bag to chest tube
| Study group | Role | What they receive |
|---|---|---|
| Clamping | Experimental | This arm will undergo chest drain clamping after a certain criteria has been met. Four hours post clamping a chest x-ray will be made, and the presence of pneumothorax will be assessed. The chest drain will be removed only in the absence of pneumothorax, if pneumothorax persists patients will stay attached to the underwater seal Receives: Other: Clamping |
| Urine bag | Active comparator | The second arm will be attached to a urine bag, and bag inflation will be measured after a certain criteria has been met. bag inflation will be assessed four hours after its attachment. Bag inflation indicates the persistence of an air leak, thus the absence of bag inflation indicates the removal of the chest drain Receives: Other: Urine bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cost
The overall cost of the patient's hospital stay
Measured: 5 to 6 days
Secondary outcomes (5)
Number of participants with re-accumulation of air after chest tube clamping or attachment to the urine bag
An important side effect to be studied
Measured: up to 5 days
total number of days with chest drain inserted
Number of days chest drain remained inserted
Measured: up to 5 days
Number of chest x-rays
Total number of chest x-rays
Measured: up to 5 days
Number of participants that faced other intervention associated side effects
Subcutaneous emphysema, tension pneumothorax and others
Measured: up to 5 days
Number of participants with chest tube re-insertion
An important side effect
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Jan 2022
- Primary completion25 Nov 2022 (estimated)
- Study completion25 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax and Air LeakStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University, Tanta University, European Institute of Oncology
- Responsible party
- Sponsor
- Investigators
- Firas Abuakar, MD, Principal investigator, Thoracic Surgery Unit, Makassed Islamic Charitable Society Hospital, Jerusalem, PalestineOsama Darras, MD candidate, Study chair, Medical Research Club, faculty of medicine, Alquds University, Jerusalem, PalestineHadeel Abedalhameed, MD candidate, Study chair, Medical Research Club, faculty of medicine, Alquds University, Jerusalem, PalestineRami Alaraj, MD candidate, Study director, Medical Research Club, faculty of medicine, Alquds University, Jerusalem, PalestineRania Attiyeh, MD candidate, Study chair, Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230420
- Sponsor's protocol ID
- 02/REC-CT/2021
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2021
- Last updated
- 8 Feb 2022
- Results posted
- 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 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries
- ClinicalTrials.gov ID
- NCT05230420
- Acronym / sponsor ID
- 02/REC-CT/2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Al-Quds UniversityUniversity, hospital or other
- Collaborators
- Assiut University, Tanta University, European Institute of Oncology
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 25 Nov 2022 (estimated)
- Study completion
- 25 Dec 2022 (estimated)
- First posted
- 8 Feb 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.
Investigators will compare two different approaches of postoperative drainage after the standard water-seal drain has been used efficiently; one is by using urine bag and check it get blown by the leaked air, two is by using clamping of the water seal drain. Investigators will compare them depending on several factors such as; cost effectiveness, hospital stay, duration of putting the drain and more, reinsertion of the chest tube and others.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clamping | Experimental | Other: ClampingThis arm will undergo chest drain clamping after a certain criteria has been met. Four hours post clamping a chest x-ray will be made, and the presence of pneumothorax will be assessed. The chest drain will be removed only in the absence of pneumothorax, if pneumothorax persists patients will stay attached to the underwater seal |
| Urine bag | Active comparator | Other: Urine bagThe second arm will be attached to a urine bag, and bag inflation will be measured after a certain criteria has been met. bag inflation will be assessed four hours after its attachment. Bag inflation indicates the persistence of an air leak, thus the absence of bag inflation indicates the removal of the chest drain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- post lung resection patients (via Uniportal VATS only)
- Over the age of 18
- indicated chest tube
Key exclusion criteria (1 listed)
- Under the age of 18
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 |
|---|---|---|
| ClampingClamping of chest tube | Other | Clamping |
| Urine bagAttachment of a urine bag to chest tube | Other | Urine bag |
Primary outcome
Overall cost
Time frame: 5 to 6 days
The overall cost of the patient's hospital stay
5 secondary outcomes
Number of participants with re-accumulation of air after chest tube clamping or attachment to the urine bag
Time frame: up to 5 days
total number of days with chest drain inserted
Time frame: up to 5 days
Number of chest x-rays
Time frame: up to 5 days
Number of participants that faced other intervention associated side effects
Time frame: up to 5 days
Number of participants with chest tube re-insertion
Time frame: up to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Pneumothorax and Air Leak
Recruiting
Feasibility and Accuracy of a Novel Pleural Drain Gas Analyzer in Detecting Air Leaks
Air Leak From Lung, Pneumothorax
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.
Firas Abuakar, MD principal investigator
Thoracic Surgery Unit, Makassed Islamic Charitable Society Hospital, Jerusalem, Palestine
Osama Darras, MD candidate study chair
Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
Hadeel Abedalhameed, MD candidate study chair
Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clamping and Urine bag in people with Pneumothorax and Air Leak and Pneumothorax, run by Al-Quds University at 4 sites in 3 countries.
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 3 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 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Egypt, Italy, Palestinian Territories. 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 Firas Abuakar, MD (052220068 ext. +972, firasabuakar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall cost (time frame: 5 to 6 days). 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 8 Feb 2022.