Awake ThoracoscopeNCT06972836
Safety and Efficacy of Awake Uniportal Video Assisted Thoracoscopic Modified Pericardial Window in Recurrent Pericardial Effusion at Mid Term Result
A study testing modified pericardial window and traditional pericardial window in people with Awake Thoracoscope and Pericardial Effusion, run by Zagazig University at 2 sites in Egypt.
Trial summary
this study compare two surgical techniues at the same time two methods of anathesia with assisstance of thoracoscope for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Awake Thoracoscope, Pericardial Effusion, Pericadiopleural Window
- What is being tested?
- modified pericardial window and traditional pericardial window
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Oct 2024to Oct 2025
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who presented with recurrent massive pericardial effusion based on clinical, radiological evidence by Echo and C.T. chest
Who cannot join
- hemodynamically unstable patients
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Amr El Sayed Tawfek
Zagazig, Sharqia Province, 44519
cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt
Zagazig, Sharqia Province, 44519
About this study
this study compare two surgical techniues at the same time two methods of anathesia with assisstance of thoracoscope for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months
Read the detailed description
this study compare two thoracoscopic techniues awake modified pericardial window and pericardial window under general anasethia for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months
- Being tested
- modified pericardial window, traditional pericardial window
- Keywords
- pericardial effusion, pericardiopleural window
- Medical subject headings
- Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified pericardial windowProcedure or surgery
(H) shaped lines done by diathemy hoke above phrenic nerve then the upper and lower pericardial flabs reflelected outward in upper and lower directions respectively then 3 large clips applied on each angle of the reflected pericardial anlgles then heavy non absorbable suture is taken from the centre of the free reflected edge to adjacent upper and lower pericardium
traditional pericardial windowProcedure or surgery
A portion of pericardium (2 cm diameter) was resected anterior to the phrenic nerve by diathermy hook
| Study group | Role | What they receive |
|---|---|---|
| Awake modified pericardial window | Experimental | H) shaped lines done by diathemy hoke above phrenic nerve then the upper and lower pericardial flabs reflelected outward in upper and lower directions respectively then 3 large clips applied on each angle of the reflected pericardial anlgles then heavy non absorbable suture is taken from the centre of the free reflected edge to adjacent upper and lower pericardium Receives: Procedure: modified pericardial window |
| General traditional pericardial window | Active comparator | A portion of pericardium (2 cm diameter) was resected anterior to the phrenic nerve by diathermy hook Receives: Procedure: traditional pericardial window |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of pericardial effusion
clinical (Beck's triad:Hypotension with a narrowed pulse pressure,jugular venous distension,distant heart sounds )and Echo findings suggestive of recurrence of pericardial effusion
Measured: follow up each month at out patient clinic for 6 months from the date of surgery
Awake anasethia
the patient is sedated -cooperative- hemodynamically stable by transthoracic spinal anasthsia at Cervical 5
Measured: from the start till the end of the procedure about 45 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start20 Oct 2024
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awake ThoracoscopeStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr Elsayed Tawfek Ibrahim, Zagazig University
- Investigators
- Amr Tawfek, as prof, Principal investigator, cardiothoracic surgery department-faculty of medecine-zagazig univeristy-Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972836
- Sponsor's protocol ID
- ZU-IRB # 739-15-10-2024
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Awake Uniportal Video Assisted Thoracoscopic Modified Pericardial Window in Recurrent Pericardial Effusion at Mid Term Result
- ClinicalTrials.gov ID
- NCT06972836
- Acronym / sponsor ID
- ZU-IRB # 739-15-10-2024
- Keywords
- pericardial effusion, pericardiopleural window
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 May 2025 (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.
this study compare two surgical techniues at the same time two methods of anathesia with assisstance of thoracoscope for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months
Detailed description
this study compare two thoracoscopic techniues awake modified pericardial window and pericardial window under general anasethia for cases of repeated collection of fluid in pericardial sac and observation the result of the two techniques on the operated patients from 3 to 6 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awake modified pericardial window | Experimental | Procedure: modified pericardial windowH) shaped lines done by diathemy hoke above phrenic nerve then the upper and lower pericardial flabs reflelected outward in upper and lower directions respectively then 3 large clips applied on each angle of the reflected pericardial anlgles then heavy non absorbable suture is taken from the centre of the free reflected edge to adjacent upper and lower pericardium |
| General traditional pericardial window | Active comparator | Procedure: traditional pericardial windowA portion of pericardium (2 cm diameter) was resected anterior to the phrenic nerve by diathermy hook |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who presented with recurrent massive pericardial effusion based on clinical, radiological evidence by Echo and C.T. chest
Key exclusion criteria (1 listed)
- hemodynamically unstable patients
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 |
|---|---|---|
| modified pericardial window(H) shaped lines done by diathemy hoke above phrenic nerve then the upper and lower pericardial flabs reflelected outward in upper and lower directions respectively then 3 large clips applied on each angle of the reflected pericardial anlgles then heavy non absorbable suture is taken from the centre of the free reflected edge to adjacent upper and lower pericardium | Procedure or surgery | Awake modified pericardial window |
| traditional pericardial windowA portion of pericardium (2 cm diameter) was resected anterior to the phrenic nerve by diathermy hook | Procedure or surgery | General traditional pericardial window |
Primary outcome
recurrence of pericardial effusion
Time frame: follow up each month at out patient clinic for 6 months from the date of surgery
clinical (Beck's triad:Hypotension with a narrowed pulse pressure,jugular venous distension,distant heart sounds )and Echo findings suggestive of recurrence of pericardial effusion
Awake anasethia
Time frame: from the start till the end of the procedure about 45 min
the patient is sedated -cooperative- hemodynamically stable by transthoracic spinal anasthsia at Cervical 5
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 15 May 2025.
- Individual participant dataSharing planned: No
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.
Amr Tawfek, as prof principal investigator
cardiothoracic surgery department-faculty of medecine-zagazig univeristy-Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified pericardial window and traditional pericardial window in people with Awake Thoracoscope and Pericardial Effusion, run by Zagazig University at 2 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
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?
recurrence of pericardial effusion (time frame: follow up each month at out patient clinic for 6 months from the date of surgery). The study lists 2 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 15 May 2025.