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
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.
- 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