Safety and Efficacy of Awake Uniportal Video Assisted Thoracoscopic Modified Pericardial Window in Recurrent Pericardial Effusion at Mid Term Result

Not Applicable

Active, not recruiting

• Conditions: Awake Thoracoscope; Pericardial Effusion; Pericadiopleural Window

• Registration Number: NCT06972836
• Lead Sponsor: Zagazig University

Brief 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

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 Timeline

• Study Start: 2024-10-20
• Study First Submitted: 2025-04-24
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• patients who presented with recurrent massive pericardial effusion based on clinical, radiological evidence by Echo and C.T. chest

Exclusion Criteria

• hemodynamically unstable patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
recurrence of pericardial effusion	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	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

Trial Locations

Locations (2)

cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt; 🇪🇬 Zagazig,,, El Sharkia, Egypt

Amr El Sayed Tawfek; 🇪🇬 Zagazig, El Sharkia, Egypt