Chest Tube, Open Heart Surgery, Retained Blood Syndrome
Conditions
Brief summary
Title: CLEAR-CS Study - Active Chest Tube Clearance After Cardiac Surgery This study looks at two methods of removing blood and fluid from the chest after heart surgery. After cardiac operations, patients usually have chest tubes placed to drain blood and fluid. Sometimes these tubes get blocked, leading to retained blood inside the chest. This can cause complications such as the need for another surgery, heart compression, or longer hospital stays. The study compares patients who received active chest tube clearance, a method designed to keep the tubes open and remove blood continuously, with patients who received standard passive chest tube drainage. Researchers will review medical records from three heart surgery centers to see which method is associated with fewer complications, less bleeding, and shorter hospital stays. No additional procedures will be performed as part of this study. Purpose: To evaluate whether active chest tube clearance improves safety and outcomes after heart surgery compared to standard drainage. Who Can Participate: This study uses data from adult patients (18 years and older) who underwent heart surgery with chest tubes placed. No new patients will be enrolled. Duration of Participation: Data from the period 2022-2024 will be analyzed. Risks and Benefits: There is no direct risk to patients, as no new procedures are being performed. The study may help improve chest drainage practices and reduce complications for future patients
Detailed description
Detailed Description This multicenter retrospective cohort study evaluates the safety and effectiveness of active chest tube clearance compared to standard passive chest tube drainage in adult patients undergoing cardiac surgery via median sternotomy. Background: Postoperative bleeding and retained blood within the chest are common complications following cardiac surgery. Retained blood can lead to Retained Blood Syndrome (RBS), which includes reoperation for bleeding, cardiac tamponade, hemothorax requiring intervention, and retained intrathoracic clot necessitating procedural management. These complications are associated with increased morbidity, longer ICU and hospital stays, and higher healthcare costs. Study Objectives: Primary Objective: Compare the incidence of RBS between patients managed with active chest tube clearance versus standard passive drainage. Secondary Objectives: Assess differences in reoperation for bleeding, cardiac tamponade, hemothorax requiring drainage, postoperative blood transfusion requirements, chest tube occlusion, postoperative atrial fibrillation, ICU length of stay, hospital length of stay, and 30-day mortality. Study Design: Type: Observational, retrospective, multicenter cohort study. Data Collection: Medical records from three tertiary cardiac surgery centers will be reviewed over a 3-year period (January 2022 - December 2024). Population: Adult patients (≥18 years) who underwent cardiac surgery (CABG, valve surgery, or combined procedures) and had mediastinal chest tubes placed. Exclusions: Redo sternotomy, acute aortic dissection surgery, heart transplantation, mechanical circulatory support implantation, incomplete medical records, or intraoperative death. Groups: Group A: Active chest tube clearance strategy Group B: Standard passive chest tube drainage Definitions: Retained Blood Syndrome (RBS): Any of reoperation for bleeding, cardiac tamponade requiring intervention, hemothorax requiring drainage, or retained clot requiring procedural management. Chest Tube Occlusion: Documented loss of drain patency requiring manipulation, flushing, or replacement. Data Collection Variables: Demographics: Age, sex, BMI Preoperative Variables: Diabetes, hypertension, chronic kidney disease, anticoagulant/antiplatelet therapy, LVEF, urgency status Operative Variables: Procedure type, cardiopulmonary bypass time, aortic cross-clamp time, number/size of chest tubes Postoperative Variables: Chest tube output, reoperation, transfusions, atrial fibrillation, ICU and hospital stay, 30-day mortality Sample Size: Approximately 200-300 patients (100-150 per group), based on case availability, providing sufficient power to detect clinically meaningful differences in RBS incidence. Statistical Analysis: Continuous variables: mean ± SD or median (IQR) Categorical variables: frequencies and percentages Between-group comparisons: Student's t-test, Mann-Whitney U test, chi-square or Fisher's exact test Multivariable logistic regression to identify independent predictors of RBS Propensity score analysis if significant baseline differences exist Center and surgeon effects will be explored and adjusted for Significance: p \< 0.05 Ethical Considerations: Retrospective, observational study No interventions beyond standard care Data anonymized and stored securely Waiver of informed consent requested due to minimal risk Potential Benefits: While no direct benefit to participants exists, the study may improve postoperative chest drainage strategies, reduce retained blood complications, and optimize perioperative outcomes in future cardiac surgery patients. Timeline: Month 0: Ethical approval Months 1-3: Data collection Month 4: Statistical analysis Months 5-6: Manuscript preparation Funding: None Conflicts of Interest: None
Interventions
None listed
Sponsors
Kasr El Aini Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) undergoing cardiac surgery via median sternotomy, including CABG, valve surgery, or combined procedures. Placement of mediastinal chest tubes postoperatively
Exclusion criteria
* Redo sternotomy Surgery for acute aortic dissection Heart transplantation Mechanical circulatory support implantation Incomplete or missing essential medical records Intraoperative death
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Retained Blood Syndrome (RBS) after cardiac surgery | "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel" | Composite outcome including reoperation for bleeding, cardiac tamponade requiring procedural intervention, hemothorax requiring additional drainage, or retained intrathoracic clot requiring procedural management. Data will be collected retrospectively from patient medical records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation for bleeding | "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel" | ny surgical re-intervention performed due to postoperative bleeding documented in the patient's medical records |
| Incidence of cardiac tamponade requiring procedural intervention | "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel" | Documented cases of cardiac tamponade after surgery that required percutaneous or surgical intervention for management |
| Incidence of hemothorax requiring additional drainage | "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel" | Cases in which postoperative hemothorax necessitated additional chest tube placement or drainage procedures |
| Incidence of chest tube occlusion | "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel" | Documented loss of chest tube patency requiring manipulation, flushing, or replacement |
| Incidence of postoperative atrial fibrillation | "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel" | Occurrence of new-onset atrial fibrillation after surgery documented in patient monitoring records or ECG reports |
| Intensive Care Unit (ICU) length of stay | "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel" | Total number of days spent in the ICU postoperatively. |
| Total hospital length of stay | "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel" | Total number of days from the day of surgery to hospital discharge. |
| All-cause mortality within 30 days postoperatively | "From end of surgery until hospital discharge or up to 30 days postoperatively, whichever occurs first, assessed by review of patient medical records by trained research personnel" | Any death occurring within 30 days after the index cardiac surgery. |
Countries
Egypt
Outcome results
None listed