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Active, not recruiting

NCT Number: NCT07814573

Early Outcomes of Spontaneous vs. Negative-pressure Drainage After Coronary Artery Bypass Grafting

The purpose of this prospective, randomized controlled clinical trial is to evaluate early postoperative outcomes and fluid drainage dynamics between continuous active negative-pressure chest drainage (-10 mmHg) and standard spontaneous closed underwater-seal drainage in adult patients undergoing elective isolated coronary artery bypass grafting (CABG).

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Drainage Complications Due to Coronary Artery Bypass Graft Coronary Artery Bypass Graft (CABG)

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

Postoperative pericardial and pleural fluid accumulation following cardiac surgery can lead to complications such as postoperative atrial fibrillation (POAF), cardiac tamponade, or symptomatic pleural effusion. While low-intensity negative-pressure suction is commonly used in general thoracic procedures, its routine application in cardiac surgery remains debated.This prospective randomized study evaluates whether maintaining continuous low-intensity active negative-pressure chest drainage (-10mmHg) during the first 48 hours postoperatively improves early fluid evacuation and reduces early morbidity compared with conventional spontaneous closed underwater-seal chest drainage.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for elective, isolated coronary artery bypass grafting (CABG) via median sternotomy.
  • Adult patients aged from 18 to 80 years.
  • Patients who provide written informed consent prior to study enrollment.

Exclusion criteria

  • Patients undergoing emergency coronary artery bypass grafting (CABG) or emergency surgical re-exploration.
  • Patients under 18 years or over 80 years of age.
  • Patients undergoing re-do cardiac surgery.
  • Pre-existing pericardial effusion or significant pleural effusion detected on baseline imaging.
  • Pre-existing baseline coagulopathy or active bleeding disorder.

Treatment and study plan

monitoring of drainage using negative pressure

Procedure

Continuous low-intensity active negative-pressure suction (-10mmHg) applied to chest drains via central vacuum wall suction for the first 48 hours postoperatively following coronary artery bypass grafting (CABG).

Primary outcomes

  1. Pre-discharge echocardiographic assessment

    Time frame: 7-14 days after the surgery

    Pericardial effusion volume and left ventricular ejection fraction (LVEF) measured in percentage (%) via transthoracic echocardiography prior to hospital discharge.

  2. Cumulative drainage volume at 24 and 48 hours

    Time frame: First 24 and 48 hours after the surgery

    Total volume of thoracic drainage fluid measured in milliliters (mL) at 24 and 48 hours postoperatively.

  3. Incidence of postoperative complications

    Time frame: It will be evaluated during the patient follow-ups at the first 48 hours and the one-month check-ups.

    Rate of early complications occurring within 48 hours postoperatively, including postoperative atrial fibrillation (POAF), pneumothorax, and symptomatic pleural effusion requiring intervention.

    Composite rate of major complications within 30 days postoperatively, including surgical re-exploration for bleeding or cardiac tamponade, requirement for extracorporeal membrane oxygenation (ECMO) support, deep sternal wound infection or sternal revision, and 30-day all-cause mortality.

Secondary outcomes

  1. Postoperative recovery metrics

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

    Intensive care unit (ICU) length of stay and total hospital length of stay measured in days

  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

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 22, 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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