The Journal of ExtraCorporeal Technology No 57-1 | Page 25

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