H. M. da Rocha Coutinho et al.: J Extra Corpor Technol 2025, 57, 105 – 112 111
Figure 4. Boxplot comparing plasma hemoglobin 24 h after CPB between groups.
necessary at a later stage to ensure optimal procedural safety, particularly if the centrifugal pump drive is off and there is no concern for shear stress on blood cells during clamping. In addition, the SafeCEC Ò valve did not cause additional damage to the blood, as evidenced by the hematological and biochemical parameters evaluated.
There was no significant difference between the groups with and without the SafeCEC Ò valve.
Conclusion
The perfusionist, responsible for conducting CPB procedures, is aware of the risks, human factors and mechanical failures that can occur during CPB. In each case, the goal is to provide a safe and uneventful perfusion process. Safe perfusion entails understanding and implementation of best practices for CPB procedures, adequate training and well-defined protocols and instructions for handling various controls for conducting a CPB procedure. Additionally, continuous monitoring of vital functions is imperative to maintain patient safety throughout CPB [ 25 ].
The SafeCEC Ò one-way valve adequately fulfills this requirement. However, this study is limited by its small sample size and single-center design. To calculate the sample size, an expected effect size of 0.50, a study power of 80 % and a significance level of 5 % were considered. This calculation yielded a requirement of 67 patients in each group, totaling 134 patients in the sample.
Given these limitations, we recommend that future studies be carried out with a larger number of patients, across different centers, with a control group without the valve, and incorporating a wider range of clinical outcomes and a cost-effectiveness analysis.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Conflicts of interest The authors declare no conflicts of interest related to this study.
Data availability statement
The datasets generated and analyzed during the current study are available from the corresponding author upon reasonable request.
Author contribution statement
H. M. R. Coutinho: Study conception, methodology, data analysis, manuscript drafting. J. H. S. A. Coutinho: Supervision, critical revision of the manuscript. G. Kikuta: Data collection, surgical procedures. R. M. R. F. Casanova and J. H. C. Torres: Perfusion management, data acquisition. E. E. Reis: Laboratory analysis, data interpretation. All authors read and approved the final manuscript. Ethics approval
This study was approved by the Ethics Committee of Hospital Universitário Pedro Ernesto – UERJ( Approval number: 41034620.3.0000.5259).
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