Cardiopulmonary bypass (CPB) is a critical component of cardiovascular surgery, but it comes with significant risks, including physiological complications, mechanical failures, and human errors. In response to these challenges, the study aimed to develop and validate a standardized checklist for CPB to enhance patient safety and procedural efficiency.
Background and Importance
CPB involves complex interactions between blood and artificial components such as oxygenators, tubes, and reservoirs. These interactions can lead to complications such as endothelial edema, neurological disorders, kidney injuries, and respiratory complications. Additionally, human errors, equipment malfunctions, and improper assembly of CPB circuits further increase the risk of adverse events. To address these concerns, leading cardiovascular organizations, including the Brazilian Society for Cardiovascular Surgery and the American Society of Extracorporeal Technology (AmSECT), recommend the use of standardized checklists. However, there is no universally accepted checklist specifically designed for CPB procedures, prompting the need for this study.
Methodology
The study employed the Delphi technique, a structured consensus-based method that involves iterative rounds of expert feedback to refine a proposed instrument. Five experienced perfusionists, each with over five years of experience, participated in the validation process.
- Initial Development: The research team conducted an extensive literature review to identify essential safety measures in CPB. This process resulted in a preliminary 42-item checklist, covering various aspects such as equipment functionality, patient preparation, and perfusion safety.
- First Delphi Round: The preliminary checklist was sent to the five experts, who evaluated each item for relevance and clarity. Based on their feedback, some items were modified, merged, or excluded, leading to a refined 37-item list.
- Second Delphi Round: Experts rated each item on a scale from 1 (strongly disagree) to 5 (strongly agree). Any item with an average score below 4.0 or a standard deviation greater than 1.0 was subject to exclusion or revision. Ultimately, the final checklist was expanded to 41 elements, ensuring comprehensive coverage of CPB safety protocols.
Results
The validation process confirmed the reliability and relevance of the developed checklist. Key findings include:
- High Agreement Among Experts: Over 90% of the items in the first round were deemed essential, demonstrating strong consensus on their importance.
- Refinements for Clarity and Efficiency: Some items were repositioned, rewritten, or merged to improve usability.
- Final Checklist Structure: The final version includes 41 elements categorized into 10 major topics, covering patient identification, equipment checks, circuit preparation, anticoagulation monitoring, and emergency procedures.
Discussion
The implementation of a CPB checklist offers several advantages:
- Error Prevention: By systematically verifying critical steps, the checklist minimizes the risk of human errors and equipment failures.
- Standardization of Practices: The checklist ensures uniform adherence to best practices, reducing variability between perfusionists and surgical teams.
- Improved Communication: A structured checklist enhances coordination among surgical team members, ensuring that no crucial step is overlooked.
- Alignment with International Guidelines: The study aligns with recommendations from global perfusion organizations, reinforcing the necessity of checklist-based protocols in cardiac surgery.
Despite these benefits, the study acknowledges some limitations. The small sample size of five experts, all from a single institution, may limit the generalizability of the findings. Future research should involve a larger, more diverse group of perfusionists across multiple healthcare centers to further validate and refine the checklist. Additionally, real-world testing of the checklist in surgical settings is needed to assess its practical impact on patient safety and surgical efficiency.
Conclusion
The study successfully developed and validated a 41-item checklist for CPB, emphasizing the importance of standardized safety protocols in cardiovascular surgery. The checklist provides a structured approach to pre-bypass preparations, enhancing patient safety and reducing procedural risks. Given its potential benefits, widespread adoption of this checklist in cardiovascular surgical centers is strongly recommended.
Study ranking = 4 (High Quality) This study is based on expert consensus using the Delphi method, a well-established technique for developing standardized protocols. However, the small sample size and lack of real-world clinical trials slightly reduce its ranking. Future studies with broader participant groups and clinical implementation would further validate its effectiveness.
