Risk factors for perfusionist-related near-miss event: A retrospective cohort study in a single center_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LIN Tianxiao , CHEN Xing , MENG Weipeng , GUAN Li ,  PENG Qinbao

1. Department of Cardiovascular Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, P. R. China;

Corresponding author：

PENG Qinbao, Email: 214317112@qq.com

Keywords：

Near-miss; perfusionist; cardiopulmonary bypass; adverse events; risk factors

DOI：

10.7507/1007-4848.202208067

Video：

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Objective To explore the risk factors and countermeasures of the perfusionist-related near-miss event (NME) in cardiopulmonary bypass (CPB). Methods The clinical data of the patients who underwent cardiac surgery in the Department of Cardiovascular Surgery, Nanfang Hospital, Southern Medical University from March 2020 to July 2021 were retrospectively analyzed. According to whether NME occurred during the operation, the patients were divided into an NME group and a non-NME group. The clinical data of the two groups were compared, and the risk factors for NME were analyzed. Results A total of 702 patients were enrolled, including 424 males and 278 females with a median age of 56.0 years. There were 125 patients in the NME group and 577 patients in the non-NME group. The occurrence rate of NME was 17.81%. Univariate analysis showed that there were statistical differences between the two groups in the gender, body surface area, CPB time, European system for cardiac operative risk evaluation score, emergency surgery, type of surgery, night CPB initiation, modified ultrafiltration use, multi-device control, average operation time, et al. (all P<0.05). The above variables were dimensionality reduction processed by least absolute shrinkage and selection operator regression, and the λ of minimum mean square error of 10-fold cross validation was 0.014. The variables of the corresponding model were selected as follows: multi-device control, night CPB initiation, minimum hematocrit, modified ultrafiltration use, CPB time. The results of multivariate logistic regression showed that night CPB initiation [OR=9.658, 95%CI (4.735. 19.701), P<0.01] and CPB time [OR=1.003, 95%CI (1.001, 1.006), P=0.014] were independent risk factors for NME. Conclusion Night CPB initiation and CPB time are independent risk factors for NME during CPB, which should be recognized and early warned in clinical work.

Citation： LIN Tianxiao, CHEN Xing, MENG Weipeng, GUAN Li, PENG Qinbao. Risk factors for perfusionist-related near-miss event: A retrospective cohort study in a single center. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2024, 31(4): 525-530. doi: 10.7507/1007-4848.202208067 Copy

1.	Condello I. Who are you then? I am part of that thing that can do evil and works good: Perfusion. Eur J Cardiothorac Surg, 2022, 62(1): ezac156.
2.	Cammertoni F, Bruno P, Pavone N, et al. Influence of cardiopulmonary bypass set-up and management on clinical outcomes after minimally invasive aortic valve surgery. Perfusion, 2021, 36(7): 679-687.
3.	王伟, 黑飞龙. 体外循环技术的质量控制和标准化. 中华医学杂志, 2017, 97(38): 2972-2974.
4.	陈瑾, 刘燕, 刘俊琰. 多中心同质化医疗质量管理在体外循环科中的应用. 中国体外循环杂志, 2019, 17(4): 211-214.
5.	胡盛寿. 中国心血管外科的技术发展现状和医疗质量控制. 手术, 2016, 1(1): 3-7.
6.	中国医院协会. 中国医院质量安全管理—第4部分: 医疗管理 (T/CHAS 10-4-6-2018). 北京, 2018.
7.	冯婷婷, 张欣, 谭玲玲, 等. 护理接近失误管理的研究进展. 中华护理杂志, 2020, 55(1): 153-157.
8.	彭勤宝, 孟维朋, 官莉, 等. 电子体外循环安全核查表的应用与效果分析. 中国体外循环杂志, 2020, 18(6): 355-359.
9.	Spiess BD, Rotruck J, McCarthy H, et al. Human factors analysis of a near-miss event: Oxygen supply failure during cardiopulmonary bypass. J Cardiothorac Vasc Anesth, 2015, 29(1): 204-209.
10.	Belway D, Tran DTT, Rubens FD. Effects of a change in entry-to-practice criteria for cardiovascular perfusion in Canada: Results of a national survey. Perfusion, 2017, 32(4): 296-300.
11.	高永祥, 张晋昕. Logistic回归分析的样本量确定. 循证医学, 2018, 18(2): 122-124.
12.	Puis L, Milojevic M, Boer C, et al. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Interact Cardiovasc Thorac Surg, 2020, 30(2): 161-202.
13.	Willcox TW, Baker RA. Incident reporting in perfusion: Current perceptions on PIRS-2. J Extra Corpor Technol, 2020, 52(1): 7-12.
14.	王立伟, 熊红燕, 易秋月, 等. 2018年至2019年陕西省体外循环不良事件分析. 中国体外循环杂志, 2021, 19(2): 73-77.
15.	Gnoni MG, Saleh JH. Near-miss management systems and observability-in-depth: Handling safety incidents and accident precursors in light of safety principles. Safety Sci, 2017, 91: 154-167.
16.	Wang S, Wang D, Huang X, et al. Risk factors and in-hospital mortality of postoperative hyperlactatemia in patients after acute type A aortic dissection surgery. BMC Cardiovasc Disord, 2021, 21(1): 431.
17.	费忠化, 蔡腾, 蔡国强, 等. 主动脉弓部置换术围术期大量输注红细胞危险因素分析. 心肺血管病杂志, 2022, 41(7): 797-800, 805.
18.	Palanzo DA, Wise RK, Woitas KR, et al. Safety and utility of modified ultrafiltration in pediatric cardiac surgery. Perfusion, 2023, 38(1): 150-155.
19.	Talwar S, Sujith NS, Rajashekar P, et al. Modified ultrafiltration and postoperative course in patients undergoing repair of tetralogy of Fallot. J Card Surg, 2021, 36(10): 3679-3687.
20.	丘俊涛, 张良, 罗新锦, 等. 主动脉夹层手术时机对预后的影响. 中华胸心血管外科杂志, 2018, 34(1): 26-31.
21.	Addis DR, Moore BA, Garner CR, et al. Case start time affects intraoperative transfusion rates in adult cardiac surgery: A single-center retrospective analysis. J Cardiothorac Vasc Anesth, 2020, 34(3): 632-639.
22.	Kenney PS, Nielsen PH, Modrau IS. Daytime-dependent cardioprotection in cardiac surgery: A large propensity-matched cohort study. Ann Thorac Surg, 2020, 110(5): 1629-1636.
23.	中国生物医学工程学会体外循环分会. 中国体外循环专业技术标准 (2021版). 中国体外循环杂志, 2021, 19(2): 67-72.
24.	Merkle F, Kurtovic D, Starck C, et al. Evaluation of attention, perception, and stress levels of clinical cardiovascular perfusionists during cardiac operations: A pilot study. Perfusion, 2019, 34(7): 544-551.
25.	Dias RD, Riley W, Shann K, et al. A tool to assess nontechnical skills of perfusionists in the cardiac operating room. J Thorac Cardiovasc Surg, 2021, 165(4): 1462-1469.
26.	Lawson C, Predella M, Rowden A, et al. Assessing the culture of safety in cardiovascular perfusion: Attitudes and perceptions. Perfusion, 2017, 32(7): 583-590.
27.	Bauer A, Benk C, Thiele H, et al. Qualification, knowledge, tasks and responsibilities of the clinical perfusionist in Germany. Interact Cardiovasc Thorac Surg, 2020, 30(5): 661-665.
28.	Bouchez S, De Somer F. The evolving role of the modern perfusionist: Insights from transesophageal echocardiography. Perfusion, 2021, 36(3): 222-232.
29.	Seshia SS, Bryan Young G, Makhinson M, et al. Gating the holes in the Swiss cheese (partⅠ): Expanding professor Reason's model for patient safety. J Eval Clin Pract, 2018, 24(1): 187-197.
30.	Stein JE, Heiss K. The Swiss cheese model of adverse event occurrence: Closing the holes. Semin Pediatr Surg, 2015, 24(6): 278-282.
31.	Gierig S, Merkle F, Pawelke C, et al. Simulation in perfusion: Evaluating the efficacy of a specific training with eye-tracking. Perfusion, 2020, 35(8): 717-723.
32.	Merkle F, Kurtovic D, Matschke A, et al. Simulation-based training of critical events during cardiopulmonary bypass: Importance of a critical events checklist. Perfusion, 2021, 36(3): 239-247.
33.	Kulat B. Perfusionist manpower survey. J Extra Corpor Technol, 2019, 51(1): P2-P4.
34.	Joyce DL, Lahr BD, Maltais S, et al. Integration of simulation components enhances team training in cardiac surgery. J Thorac Cardiovasc Surg, 2018, 155(6): 2518-2524.
35.	Kennedy-Metz LR, Wolfe HL, Dias RD, et al. Surgery task load index in cardiac surgery: Measuring cognitive load among teams. Surg Innov, 2020, 27(6): 602-607.
36.	Tomizawa Y, Aoki H, Suzuki S, et al. Eye-tracking analysis of skilled performance in clinical extracorporeal circulation. J Artif Organs, 2012, 15(2): 146-157.
37.	Yamada Y, Nakamura T, Yamada M, et al. Use of augmented reality to assist teaching for future perfusionists in extracorporeal technology. J Extra Corpor Technol, 2019, 51(4): 244-247.
38.	Zenati MA, Leissner KB, Zorca S, et al. First reported use of team cognitive workload for root cause analysis in cardiac surgery. Semin Thorac Cardiovasc Surg, 2019, 31(3): 394-396.

1. Condello I. Who are you then? I am part of that thing that can do evil and works good: Perfusion. Eur J Cardiothorac Surg, 2022, 62(1): ezac156.
2. Cammertoni F, Bruno P, Pavone N, et al. Influence of cardiopulmonary bypass set-up and management on clinical outcomes after minimally invasive aortic valve surgery. Perfusion, 2021, 36(7): 679-687.
3. 王伟, 黑飞龙. 体外循环技术的质量控制和标准化. 中华医学杂志, 2017, 97(38): 2972-2974.
4. 陈瑾, 刘燕, 刘俊琰. 多中心同质化医疗质量管理在体外循环科中的应用. 中国体外循环杂志, 2019, 17(4): 211-214.
5. 胡盛寿. 中国心血管外科的技术发展现状和医疗质量控制. 手术, 2016, 1(1): 3-7.
6. 中国医院协会. 中国医院质量安全管理—第4部分: 医疗管理 (T/CHAS 10-4-6-2018). 北京, 2018.
7. 冯婷婷, 张欣, 谭玲玲, 等. 护理接近失误管理的研究进展. 中华护理杂志, 2020, 55(1): 153-157.
8. 彭勤宝, 孟维朋, 官莉, 等. 电子体外循环安全核查表的应用与效果分析. 中国体外循环杂志, 2020, 18(6): 355-359.
9. Spiess BD, Rotruck J, McCarthy H, et al. Human factors analysis of a near-miss event: Oxygen supply failure during cardiopulmonary bypass. J Cardiothorac Vasc Anesth, 2015, 29(1): 204-209.
10. Belway D, Tran DTT, Rubens FD. Effects of a change in entry-to-practice criteria for cardiovascular perfusion in Canada: Results of a national survey. Perfusion, 2017, 32(4): 296-300.
11. 高永祥, 张晋昕. Logistic回归分析的样本量确定. 循证医学, 2018, 18(2): 122-124.
12. Puis L, Milojevic M, Boer C, et al. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Interact Cardiovasc Thorac Surg, 2020, 30(2): 161-202.
13. Willcox TW, Baker RA. Incident reporting in perfusion: Current perceptions on PIRS-2. J Extra Corpor Technol, 2020, 52(1): 7-12.
14. 王立伟, 熊红燕, 易秋月, 等. 2018年至2019年陕西省体外循环不良事件分析. 中国体外循环杂志, 2021, 19(2): 73-77.
15. Gnoni MG, Saleh JH. Near-miss management systems and observability-in-depth: Handling safety incidents and accident precursors in light of safety principles. Safety Sci, 2017, 91: 154-167.
16. Wang S, Wang D, Huang X, et al. Risk factors and in-hospital mortality of postoperative hyperlactatemia in patients after acute type A aortic dissection surgery. BMC Cardiovasc Disord, 2021, 21(1): 431.
17. 费忠化, 蔡腾, 蔡国强, 等. 主动脉弓部置换术围术期大量输注红细胞危险因素分析. 心肺血管病杂志, 2022, 41(7): 797-800, 805.
18. Palanzo DA, Wise RK, Woitas KR, et al. Safety and utility of modified ultrafiltration in pediatric cardiac surgery. Perfusion, 2023, 38(1): 150-155.
19. Talwar S, Sujith NS, Rajashekar P, et al. Modified ultrafiltration and postoperative course in patients undergoing repair of tetralogy of Fallot. J Card Surg, 2021, 36(10): 3679-3687.
20. 丘俊涛, 张良, 罗新锦, 等. 主动脉夹层手术时机对预后的影响. 中华胸心血管外科杂志, 2018, 34(1): 26-31.
21. Addis DR, Moore BA, Garner CR, et al. Case start time affects intraoperative transfusion rates in adult cardiac surgery: A single-center retrospective analysis. J Cardiothorac Vasc Anesth, 2020, 34(3): 632-639.
22. Kenney PS, Nielsen PH, Modrau IS. Daytime-dependent cardioprotection in cardiac surgery: A large propensity-matched cohort study. Ann Thorac Surg, 2020, 110(5): 1629-1636.
23. 中国生物医学工程学会体外循环分会. 中国体外循环专业技术标准 (2021版). 中国体外循环杂志, 2021, 19(2): 67-72.
24. Merkle F, Kurtovic D, Starck C, et al. Evaluation of attention, perception, and stress levels of clinical cardiovascular perfusionists during cardiac operations: A pilot study. Perfusion, 2019, 34(7): 544-551.
25. Dias RD, Riley W, Shann K, et al. A tool to assess nontechnical skills of perfusionists in the cardiac operating room. J Thorac Cardiovasc Surg, 2021, 165(4): 1462-1469.
26. Lawson C, Predella M, Rowden A, et al. Assessing the culture of safety in cardiovascular perfusion: Attitudes and perceptions. Perfusion, 2017, 32(7): 583-590.
27. Bauer A, Benk C, Thiele H, et al. Qualification, knowledge, tasks and responsibilities of the clinical perfusionist in Germany. Interact Cardiovasc Thorac Surg, 2020, 30(5): 661-665.
28. Bouchez S, De Somer F. The evolving role of the modern perfusionist: Insights from transesophageal echocardiography. Perfusion, 2021, 36(3): 222-232.
29. Seshia SS, Bryan Young G, Makhinson M, et al. Gating the holes in the Swiss cheese (partⅠ): Expanding professor Reason's model for patient safety. J Eval Clin Pract, 2018, 24(1): 187-197.
30. Stein JE, Heiss K. The Swiss cheese model of adverse event occurrence: Closing the holes. Semin Pediatr Surg, 2015, 24(6): 278-282.
31. Gierig S, Merkle F, Pawelke C, et al. Simulation in perfusion: Evaluating the efficacy of a specific training with eye-tracking. Perfusion, 2020, 35(8): 717-723.
32. Merkle F, Kurtovic D, Matschke A, et al. Simulation-based training of critical events during cardiopulmonary bypass: Importance of a critical events checklist. Perfusion, 2021, 36(3): 239-247.
33. Kulat B. Perfusionist manpower survey. J Extra Corpor Technol, 2019, 51(1): P2-P4.
34. Joyce DL, Lahr BD, Maltais S, et al. Integration of simulation components enhances team training in cardiac surgery. J Thorac Cardiovasc Surg, 2018, 155(6): 2518-2524.
35. Kennedy-Metz LR, Wolfe HL, Dias RD, et al. Surgery task load index in cardiac surgery: Measuring cognitive load among teams. Surg Innov, 2020, 27(6): 602-607.
36. Tomizawa Y, Aoki H, Suzuki S, et al. Eye-tracking analysis of skilled performance in clinical extracorporeal circulation. J Artif Organs, 2012, 15(2): 146-157.
37. Yamada Y, Nakamura T, Yamada M, et al. Use of augmented reality to assist teaching for future perfusionists in extracorporeal technology. J Extra Corpor Technol, 2019, 51(4): 244-247.
38. Zenati MA, Leissner KB, Zorca S, et al. First reported use of team cognitive workload for root cause analysis in cardiac surgery. Semin Thorac Cardiovasc Surg, 2019, 31(3): 394-396.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Risk factors for perfusionist-related near-miss event: A retrospective cohort study in a single center

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