J Extra Corpor Technol 2025 , 57 , 18 – 23 Ó The Author ( s ), published by EDP Sciences , 2025 https :// doi . org / 10.1051 / ject / 2024030
Available online at : ject . edpsciences . org
ORIGINAL ARTICLE
Development and validation of a checklist for cardiopulmonary bypass
Valdir Assis dos Reis Filho * , Karina Aparecida Antonelli Novello , and Mariana Leticia Matias
Division of Cardiovascular Surgery , Instituto Dante Pazzanese de Cardiologia , Av . Dr . Dante Pazzanese , 500 – Vila Mariana , São Paulo – SP , 04012-909 , Brazil
Received 9 July 2024 , Accepted 21 October 2024
Abstract – Introduction : Risk prevention protocols related to patient care have been developed to reduce the incidence of adverse events in health care services . Cardiopulmonary bypass ( CPB ) can trigger several complications , including physiological problems , electrical , mechanical , and human failures , or defective components . In order to promote patient safety and the identification of failures before they can cause damage , it is necessary to the use of a checklist for all surgeries . Objective : To prepare and validate a checklist for cardiopulmonary bypass . Methodology : A consensus validation methodology is applied in this study , in which the Delphi technique was structured for the instrument ’ s development . Five perfusion experts , with at least five years of experience , had an active participation in this research . First , a questionnaire was structured , based on a comprehensive review of the relevant literature . Then , two rounds of assessments were conducted , allowing for the collection of experts ’ opinions . Results : In the first moment , a 42-item list was prepared and sent to the five experts for analysis . Based on participant ’ s responses , certain elements were accepted , excluded , and suggested . After that , a second 37-item list was assessed by the experts , resulting in all 37 items having an average assessment of 4 and a standard deviation 1.0 of acceptance . Based on these results , a 41-element checklist was developed , and these elements were considered crucial and relevant for the concerned analysis . Conclusion : The use of specific checklists for cardiopulmonary bypass comes into view as a highly proficient strategy , capable of promoting substantial improvements in the procedure safety and quality . The implementation and approval of this checklist should be considered .
Key words : Cardiopulmonary bypass , Checklist , Patient safety .
Introduction
Risk prevention protocols related to patient care have been developed to reduce the incidence of adverse events in health care services . These measures aim at promoting patient safety and the identification of failures before they can cause damage . Therefore , to develop efficient prevention actions , it is important to know the more critical processes that , as a consequence , are more prone to occur [ 1 , 2 ].
Cardiopulmonary bypass ( CPB ) can trigger several complications that are mainly related to the interaction between blood and non-endothelial circuits of oxygenators , tubes , and reservoirs . The CPB effects on the body can result in endothelial edema , respiratory complications , neurological disorders , kidney injury , and post-surgery bleeding [ 3 , 4 ]. CPB presents not only physiological changes , but also carries risks if done incorrectly , whether due to mistakes during the circuit assembly or defective components . Failures can be electrical or mechanical , encompassing a wide range of events , such as cracks ,
* Corresponding author : valdir _ assisf @ hotmail . com disconnections , air embolism , hemolysis , blood or gas flow obstruction , heat exchanger leakage or malfunctioning , and air blender malfunctioning [ 5 , 6 ].
According to the guidelines proposed by the Sociedade Brasileira de Cirurgia Cardiovascular ( SBCCV , Brazilian Society for Cardiovascular Surgery ) and Sociedade Brasileira de Circulação Extracorpórea ( SBCEC , Brazilian Society for Extracorporeal Circulation ), the clinical perfusionist must use a checklist for all surgeries . These lists must be used as a checking guide , where each completed step must be checked and confirmed . Preferably , the checklist should be filled out by two individuals , one of them being the main perfusionist . However , if a second professional is not available at the time of checking , it is crucial to adopt a systematic-oriented routine of the list items to minimize the occurrence of adverse events [ 7 , 8 ]. The American Society of Extracorporeal Technology ( AmSECT ), recommends that checklists shall be included as part of the patient ’ s permanent medical record [ 9 ].
Adequate preparation is essential to ensure patient safety during CPB , with patient safety considered inseparable from the quality of healthcare . European guidelines recommend the
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