Drainage Technique in CABG

Assiut University

Status: Not yet enrolling

Conditions: CABG; Atrial Fibrillation (AF)

Study type: Observational

Funder types: Other

Identifiers

NCT07194798

Drainage technique in CABG

Details and patient eligibility

About

aims to compare the efficacy of the posterior pericardial window versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, while assessing their impact on hospital and ICU stay, pericardial effusions, re exploration for bleeding, post-operative blood transfusions, and mortality.

Full description

Coronary artery bypass grafting (CABG) is a cornerstone in the management of advanced coronary artery disease, yet it carries a notable risk of postoperative complications. Among these, postoperative atrial fibrillation (POAF) is particularly common, affecting up to 40% of patients and contributing to increased morbidity, prolonged ICU and hospital stays, and elevated healthcare costs.

Pericardial effusion and tamponade are also frequent sequelae after CABG operation, often exacerbating the risk of POAF and necessitating re-intervention. Traditionally, retro-cardiac drains have been used to evacuate pericardial fluid, but their efficacy in preventing effusion-related complications is limited.

The posterior pericardial window (PPW) technique has emerged as a promising alternative, offering improved drainage and reduced incidence of POAF, early and late pericardial effusion, and tamponade. Studies have shown that PPW may also shorten ICU and hospital stays, reduce pleural effusion, and lower the need for revision surgery due to bleeding.

Despite encouraging data, randomized trials directly comparing PPW and retro-cardiac drains remain scarce. This study aims to fill that gap by evaluating the effectiveness of PPW versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, with secondary outcomes including pleural effusion, ICU/hospital stay duration, revision surgery, and mortality.

Enrollment: 122 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (aged 18 and above) scheduled for elective, first-time coronary artery bypass grafting (CABG).
• Patients with preserved left ventricular function (ejection fraction ≥ 35%).
• Ability to provide informed consent and comply with follow-up protocols.
• No prior history of atrial fibrillation or other significant arrhythmias.

Exclusion criteria

• Patients undergoing combined cardiac procedures (e.g., valve repair or replacement).
• Emergency CABG cases or re-operations.
• Known bleeding disorders or ongoing anticoagulation therapy that cannot be paused.
• Severe pericardial adhesions or anatomical abnormalities preventing safe creation of a posterior pericardial window.
• Chronic pulmonary disease or pleural pathology that may interfere with drainage assessment.
• Patients with active infections or systemic inflammatory conditions.

Trial design

122 participants in 2 patient groups

Group 1: 61 patients undergoing CABG will have a posterior pericardial window created for drainage.

Description:

Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group). * Group I (Posterior Pericardial Window group): 61 patients undergoing CABG will have a posterior pericardial window created for drainage. * Group II (Retro-cardiac Drain group): 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage.

Group 2 : 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage.

Description:

Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group). * Group I (Posterior Pericardial Window group): 61 patients undergoing CABG will have a posterior pericardial window created for drainage. * Group II (Retro-cardiac Drain group): 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage.