Complications Due to Coronary Artery Bypass Graft, Coronary Artery Bypass Graft (CABG), Drainage
Conditions
Keywords
drainage, cabg, coronary artery bypass graft, cardiovascular surgery, cardiac surgery
Brief summary
Cardiovascular surgery clinics currently employ drainage monitoring methods involving both negative pressure and non-negative pressure systems. Literature reviews indicate that while drainage monitoring using negative pressure has been evaluated in thoracic surgery studies, it has not been assessed in the context of cardiovascular surgery patients. This study was designed to determine the risk-benefit profile of negative pressure drainage monitoring in patients undergoing open-heart surgery and to ascertain whether negative pressure influences the incidence or volume of postoperative tamponade or pericardial effusion.
Detailed description
During the routine postoperative monitoring of chest tube drainage, patients in the study group will undergo negative pressure drainage; a pressure of approximately -10 mmHg will be applied to the drain site for 48 hours via a hose connected to the hospital's central negative pressure system. Apart from this, all groups will receive standard postoperative care for Coronary Artery Bypass Graft patients, with no other differences in procedures, medications, or treatments between the groups. Negative pressure drainage is already a standard practice in the clinics involved. Drainage output and early-stage complications (atrial fibrillation, pneumothorax, pleural effusion) will be monitored over the first 48 hours for a total of 400 patients (200 per study group). Subsequently, prior to discharge, patients will undergo echocardiography to assess for pericardial effusion and evaluate the ejection fraction. Finally, patients will be monitored for major complications-such as re-exploration for tamponade or bleeding, ECMO use, wound site revision, or mortality-up to one month post-operation. No additional clinic visits or appointments will be required for the patients during this process.
Interventions
PROCEDUREmonitoring of drainage using negative pressure
During the routine postoperative monitoring of drainage, negative pressure (approximately -10 mmHg) will be applied for 48 hours to the drainage sites of patients in the study group via a tube connected to the hospital's negative pressure system. Apart from this, all groups will undergo routine monitoring for Coronary Artery Bypass Graft patients, and there will be no other differences in procedures, medications, or treatments between the groups. Negative-pressure drainage monitoring is already in use at the clinics.
Sponsors
Başakşehir Çam & Sakura City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing coronary artery bypass graft surgery * Age range of 18-80 * Elective operations
Exclusion criteria
* Emergency operations * Patients under 18 and over 80 years of age * Reoperations * Patients with significant preoperative pleural or pericardial effusion * Patients with known coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pericardial Effusion | 7-14 days after the surgery | Pericardial effusion will be evaluated via a postoperative follow-up echocardiography performed 7-14 days after the operation. |
| 0-24 and 0-48Hrs Drainage | First 24 and 48 hours after the surgery | total drainage volume in the first 24 and 48 hours after coronary artery bypass graft surgery |
| postoperative complications | It will be evaluated during the patient follow-ups at the first 48 hours and the one-month check-ups. | Postoperative complications such as new-onset atrial fibrillation, pneumothorax, pleural effusion, re-exploration for bleeding, re-exploration for tamponade, need for ECMO, death, and sternal wound infection will be evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intensive care and hospital stay durations | from surgery to discharge (5-30 days) | It will be considered the period extending from the surgery until discharge. |
| Duration of intubation | 10-360 hours | the time elapsed from the point of intubation at the start of the operation until extubation |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTORSüleyman Yazıcı, MD, Assoc. Prof.
BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
Outcome results
None listed