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Active, not recruiting

NCT Number: NCT07814573

Comparison of Early-stage Outcomes of Spontaneous Drainage Versus Negative-pressure Drainage Monitoring in Patients Undergoing Coronary Artery Bypass Grafting: a Prospective Randomized Controlled Study

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam Ve Sakura Şehir Hastanesi

Istanbul, 34480, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

monitoring of drainage using negative pressure

Procedure

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.

Primary outcomes

  1. Pericardial Effusion

    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.

  2. 0-24 and 0-48Hrs Drainage

    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

  3. postoperative complications

    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.

Secondary outcomes

  1. intensive care and hospital stay durations

    Time frame: from surgery to discharge (5-30 days)

    It will be considered the period extending from the surgery until discharge.

  2. Duration of intubation

    Time frame: 10-360 hours

    the time elapsed from the point of intubation at the start of the operation until extubation

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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