20 V . A . dos Reis Filho et al .: J Extra Corpor Technol 2025 , 57 , 18 – 23
[ Brazilian Society for Extracorporeal Circulation ] and working in the area for at least 5 years have participated in the research . Each one of them was invited through an informative letter in which the study description and all stages were duly outlined . Also , the participants signed the Informed Consent Form ( ICF ) and were free to withdraw from the research at any moment .
An initial questionnaire was developed based on relevant contents selected according to the project ’ s purpose . A detailed review of the literature was made , focused on the pre-bypass care and aiming at finding the information required for a safe perfusion . Based on these findings , essential safety actions were identified in the cardiopulmonary bypass practice , which became the items to be checked for the instrument in making . This preliminary list had 42 items and , based on them , the instrument was sent to the subjects , and it was requested that they would accept or exclude the list stages during the first interaction , by marking YES or NO in the appropriate field . Also , the experts were encouraged to , if they wished to , include new tasks to the list , combine existing items , or provide further comments . This stage was the first Delphi questionnaire round , in which the responses were collected and analyzed , and the agreement and disagreement points were identified for the elements in the preliminary list . The score over 90 % of acceptance would be kept on the list .
Based on the expert ’ s responses in the first round , a second list containing 37 items was prepared and sent once again to the subjects . A 1 – 5 scale was used to assess the importance and relevance of each item ( 1 = totally disagree and 5 = totally agree ). The subjects were invited to review and reassess the scores , based on the results and feedback obtained in the previous round . A report was prepared with a summary of the results obtained in the first round .
The experts could attribute the score and had the opportunity to provide additional comments or rationale to the assessment . These comments were important to refine the understanding of results and provide valuable insights for the decision-making process . The comments and suggestions were considered in the refinement phase of the checklist .
According to the responses given by experts in the second round , the items that were not consistent with the statistical criteria of mean 4andSD 1 . 0 would be excluded from the checklist . The final version was based on these results .
Results
The first round revealed a high agreement level between the five specialists when it comes to most of the items assessed in the questionnaire . Out of the 42 elements on the list , 38 had an approval score over 90 %, marked as “ YES ”, showing strong consensus points among the specialists in the preliminary questionnaire . However , it is important to point out that 4 items ( Custodiol Solution ; Volts – 110 / 220 ; Level Sensor ; Bubble Sensor ) were scored under 90 % or did not receive enough responses to determine a clear consensus . The percentage of approved items in a total of 42 was approximately 90.48 % ( 38 ) and the percentage of non-approved items was approximately 9.52 % ( 4 ). These results highlighted the need for a
Table 2 . Final list with 37 elements that were assessed as mean 4 and SD 1.02 .
Items version 2 |
Mean |
SD |
Patient 01 Identification / Weight / Height |
4.4 |
0.54 |
02 Pathology |
4.4 |
0.54 |
03 Surgical procedure |
4.4 |
0.89 |
04 Calculations ( heparin / flows ) |
4.8 |
0.44 |
05 Blood products checking |
4.8 |
0.44 |
Equipment 06 Equipment clean |
4.6 |
0.54 |
07 Power cables |
4.6 |
0.89 |
08 Heater-cooler |
4.8 |
0.44 |
CPB machine 09 Initial test ( Rollers / Water lines / Heat exchanger ) |
4.8 |
0.44 |
10 Hand crank |
4.8 |
0.44 |
11 Level sensor |
4.0 |
0.63 |
12 Bubble sensor |
4.2 |
0.44 |
13 Battery |
4.6 |
0.89 |
Centrifugal pump 14 Console / Driver / Battery |
4.4 |
0.89 |
15 Flow sensor |
4.8 |
0.44 |
16 Manual hand crank |
4.8 |
0.44 |
17 Operational test |
4.4 |
0.54 |
Gas supply 18 O2 / air regulation valve |
4.6 |
0.54 |
19 Lines : O2 / Air ( Connected ) |
4.6 |
0.54 |
20 Blender / Flowmeter / FIO2 |
4.6 |
0.54 |
Materials 21 Pharmacy kit |
4.6 |
0.54 |
22 Oxygenator and components |
4.4 |
0.89 |
23 Reynald clamps for tubes |
4.4 |
0.89 |
24 Ice |
4.6 |
0.89 |
Circuit preparation 25 Safely connecting the tubes |
4.8 |
0.44 |
26 Perfusate |
5.0 |
0.0 |
27 Calibration of the arterial roller and aspirators |
4.4 |
0.54 |
28 Air removal from the system |
4.6 |
0.54 |
29 No leakage in the circuit |
4.4 |
0.54 |
Cardioplegia 30 Test in the cardioplegia module |
4.2 |
0.83 |
31 Circuit assembly / checking |
4.4 |
0.54 |
32 Cardioplegia solution |
4.2 |
0.97 |
Vacuum system 33 Vacuum regulator |
4.6 |
0.89 |
34 Relief valve |
5.0 |
0.0 |
Before Starting CPB 35 Heparin dosage |
4.4 |
0.54 |
36 Anticoagulation / ACT |
4.6 |
0.54 |
37 Arterial line test |
5.0 |
0.0 |
* CPB – cardiopulmonary bypass ; ACT – activated coagulation time .
deeper analysis and additional discussions for the subsequent Delphi questionnaire rounds ( Table 1 ).
Therefore , 2 items ( Custodiol Solution ; Volts – 110 / 220 ) were excluded for not complying with the 90 % of acceptance condition , and 4 ( Pathology ; Equipment Clean ; Machine Battery ; Ice ) were included as a suggestion by the specialists . Ten elements were rewritten or repositioned ( Heater ; Cooler ; Initial Test ; Rollers ; Water Lines ; Heat Exchanger ; Driver ; Pump Battery ; Blender – FIO2 , Flowmeter ), resulting in a more