V . A . dos Reis Filho et al .: J Extra Corpor Technol 2025 , 57 , 18 – 23 19
use of an institution-approved checklist before and during CPB , in the perioperative period ( weaning from CPB , post-CPB , emergent reinstitution of CPB ), and in procedures performed by clinical perfusionists [ 10 ]. AmSECT also recommends that the perfusionist should employ a checklist for additional perfusion services such as autotransfusion , intra-aortic balloon pump , and extracorporeal membrane oxygenation ( ECMO ) [ 9 ].
Human failure and poor maintenance of devices can contribute to the occurrence of accidents . The surgical team interaction , the early diagnosis , and the prompt intervention have shown to be crucial for a favorable outcome . Therefore , the clinical perfusionist plays a crucial role in cardiopulmonary bypass procedures , and their involvement is of utmost importance [ 6 ]. The perfusionist needs to adhere strictly to established procedures to ensure patient safety throughout the entire duration of CPB [ 11 ].
The assembly of the extracorporeal circuit and the inspection for potential failures in the perfusion equipment before its clinical use are important . The technological progress is evident , like the incorporation of alarms and fail-safe devices , but care continues to be vital for conducting CPB . However , the perfusionist ’ s attention to detail and adherence to pre-bypass checklists are still the foundation for a safe practice . Human error is the leading cause of accidents , even more than mechanical failure . CPB equipment test needs to be carried out to ensure roller pumps and heater / coolers are functioning well . As for the centrifugal pump console , it must be checked to observe potential electrical power failure ; the most common method to do so is temporarily disconnecting the energy line from the console and checking if the backup battery alarm is fully operational . After the CPB circuit is assembled , the oxygenator and blood reservoir are placed in their proper support . The gas supply connection , the arterial flow pump tubes , and the roller lines should be safely connected ; after that , the rollers must be properly calibrated . The two water lines of the heat exchanger are connected to the oxygenator , then water starts to flow to ensure there is no leakage [ 11 , 12 ].
The checklist format is a process of continuous monitoring capable of developing efficient prevention actions , improving the cardiopulmonary bypass practice , and providing safer support to patients during a surgical procedure . The objective of the research was to develop and validate a checklist for cardiopulmonary bypass .
Methodology
A validation methodology based on expert consensus was applied in this study , using the Delphi technique to develop and evaluate the instrument . The Delphi method , a structured communication process , involves multiple rounds of questionnaires , allowing experts to revise their responses based on feedback until a consensus is reached . In this study , two rounds were conducted to develop the checklist . The research was conducted from March to May 2023 . The study was approved by the Research Ethics Committee of the Instituto Dante Pazzanese de Cardiologia ( IDPC ) – São Paulo , with the CAAE [ Certificate of Presentation for Ethical Appreciation ] number : 67490723.5.0000.5462 .
Table 1 . Preliminary list with 42 elements . The score over 90 % of acceptance would be kept on the list .
Items version 1 |
Validity of the item |
Patient |
01 Identification / Weight / Height |
Valid |
02 Surgical procedure |
Valid |
03 Calculations ( Heparin / Flows ) |
Valid |
04 Blood products checking |
Valid |
Equipment |
05 Power cables |
Valid |
06 Cooler |
Rewritten / Repositioned |
07 Heater |
Rewritten / Repositioned |
08 Volts – 110 / 220 |
Excluded |
CPB Machine |
09 Initial test |
Rewritten / Repositioned |
10 Hand crank |
Valid |
11 Level sensor |
Valid , not supported |
exclusion |
12 Bubble sensor |
Valid , not supported |
exclusion |
13 Rollers |
Rewritten / Repositioned |
14 Water lines |
Rewritten / Repositioned |
15 Heat exchanger |
Rewritten / Repositioned |
Centrifugal pump |
16 Console |
Valid |
17 Flow sensor |
Valid |
18 Manual hand crank |
Valid |
19 Operational test |
Valid |
20 Driver |
Rewritten / Repositioned |
21 Pump battery |
Rewritten / Repositioned |
Gas supply |
22 O2 / Air regulation valve |
Valid |
23 Lines : O2 / Air ( connected ) |
Valid |
24 Blender – FIO2 |
Rewritten / Repositioned |
25 Flowmeter |
Rewritten / Repositioned |
Materials |
26 Pharmacy kit |
Valid |
27 Oxygenator and components |
Valid |
28 Reynald clamps for tubes |
Valid |
Circuit preparation |
29 Safely connecting the tubes |
Valid |
30 Perfusate |
Valid |
31 Calibration of the arterial roller and |
Valid |
aspirators |
32 Air Removal from the system |
Valid |
33 No Leakage in the circuit |
Valid |
Cardioplegia |
34 Test in the cardioplegia module |
Valid |
35 Circuit assembly / Checking |
Valid |
36 Cardioplegia solution |
Valid |
37 Custodiol solution |
Excluded |
Vacuum system |
38 Vacuum regulator |
Valid |
39 Relief valve |
Valid |
Before starting CPB |
40 Heparin dosage |
Valid |
41 Anticoagulation / ACT |
Valid |
42 Arterial line test |
Valid |
CPB – cardiopulmonary bypass ; ACT – activated coagulation time .
Five clinical perfusionists with specialization recognized by the Sociedade Brasileira de Circulação Extracorpórea