Başakşehir Çam Ve Sakura Şehir Hastanesi
Istanbul, 34480, Turkey (Türkiye)
NCT Number: NCT07814573
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Istanbul, 34480, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 7-14 days after the surgery
Pericardial effusion will be evaluated via a postoperative follow-up echocardiography performed 7-14 days after the operation.
Time frame: First 24 and 48 hours after the surgery
total drainage volume in the first 24 and 48 hours after coronary artery bypass graft surgery
Time frame: 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.
Time frame: from surgery to discharge (5-30 days)
It will be considered the period extending from the surgery until discharge.
Time frame: 10-360 hours
the time elapsed from the point of intubation at the start of the operation until extubation
Başakşehir Çam & Sakura City Hospital
Other Gov
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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