Evaluation of Integrated Arterial Filter Oxygenator vs. External Arterial Filters on Clinical Outcomes and Neurocognitive Function in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Trial (RCT)
ABSTRACT Background and Aims Innovative advancements in cardiopulmonary bypass (CPB) configurations, such as surface coating, blood filtration, and miniaturization, aim to reduce gaseous microemboli (GME) that contribute to embolic organ damage, particularly neurological dysfunction. Arterial line f...
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Wiley
2025-05-01
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| Online Access: | https://doi.org/10.1002/hsr2.70741 |
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| author | Vishal Vinayak Bhende Mathangi Krishnakumar Dushyantkumar Mukundbhai Parmar Arunkumar Ghanshyambhai Rudakiya Tanishq Shashikant Sharma Amit Kumar Paresh Dilip Nerurkar Saptak Piyush Mankad Mamta Roshan Patel |
| author_facet | Vishal Vinayak Bhende Mathangi Krishnakumar Dushyantkumar Mukundbhai Parmar Arunkumar Ghanshyambhai Rudakiya Tanishq Shashikant Sharma Amit Kumar Paresh Dilip Nerurkar Saptak Piyush Mankad Mamta Roshan Patel |
| author_sort | Vishal Vinayak Bhende |
| collection | DOAJ |
| description | ABSTRACT Background and Aims Innovative advancements in cardiopulmonary bypass (CPB) configurations, such as surface coating, blood filtration, and miniaturization, aim to reduce gaseous microemboli (GME) that contribute to embolic organ damage, particularly neurological dysfunction. Arterial line filters are effective in mitigating embolism risk. Neurological complications post‐cardiac surgery can result from reduced cerebral blood flow, embolic materials, and other factors, including anesthesia. This study evaluates the impact of integrated arterial filter oxygenator (IAF‐Oxy.) versus external arterial filters (EAF) on clinical outcomes in pediatric patients undergoing surgery for congenital heart disease (CHD). Methods This prospective randomized controlled trial included 100 pediatric patients undergoing cardiac surgery under CPB. Patients were randomized into two groups: Group A included external arterial filters (EAF) with membrane oxygenators such as Capiox Baby RX 05 and others, while Group B included integrated arterial filters (IAF) with oxygenators like Capiox Baby FX 05. The outcomes were neurological function, mechanical ventilation time (hours), intensive care unit stay (hours), and hospital stay (days). Results Group B demonstrated significantly lower mean aortic cross‐clamp (70.2 ± 38.5 vs. 88.0 ± 49.7 min; p = 0.04) and CPB times (104 ± 48.1 vs. 128 ± 66 min; p = 0.03). Postoperative FOUR scores were identical (16 out of 16) in both groups. Median ventilation time (26.5 [24.25–125.25] hours in Group A vs. 25.0 [12.0–50.0] hours in Group B; p = 0.258), CSICU stay (120.0 [72.0–216.0] hours in Group A vs. 108.0 [72.0–162.0] hours in Group B; p = 0.358), and hospital stay (13 ± 11 days in Group A vs. 10 ± 5 days in Group B; p = 0.138) were comparable between groups. Conclusion Integrated arterial filter oxygenator may serve as an alternative to external arterial filters, potentially reducing gaseous microemboli. IAF‐Oxy. could improve clinical outcomes, reduce CSICU and hospital stays, and enhance care for pediatric congenital heart disease (CHD) patients. |
| format | Article |
| id | doaj-art-315f7ca3c2d042af8a547422f0503b83 |
| institution | Kabale University |
| issn | 2398-8835 |
| language | English |
| publishDate | 2025-05-01 |
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| spelling | doaj-art-315f7ca3c2d042af8a547422f0503b832025-08-20T03:39:21ZengWileyHealth Science Reports2398-88352025-05-0185n/an/a10.1002/hsr2.70741Evaluation of Integrated Arterial Filter Oxygenator vs. External Arterial Filters on Clinical Outcomes and Neurocognitive Function in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Trial (RCT)Vishal Vinayak Bhende0Mathangi Krishnakumar1Dushyantkumar Mukundbhai Parmar2Arunkumar Ghanshyambhai Rudakiya3Tanishq Shashikant Sharma4Amit Kumar5Paresh Dilip Nerurkar6Saptak Piyush Mankad7Mamta Roshan Patel8Department of Pediatric Cardiac Surgery, Bhanubhai and Madhuben Patel Cardiac Centre Shree Krishna Hospital, Bhaikaka University Karamsad Gujarat IndiaDepartment of Anaesthesiology St. John's Medical College Hospital BengaluruDepartment of Perfusion Technology, Bhanubhai and Madhuben Patel Cardiac Centre Shree Krishna Hospital, Bhaikaka Univesity Gujarat IndiaDepartment of Perfusion Technology, Bhanubhai and Madhuben Patel Cardiac Centre Shree Krishna Hospital, Bhaikaka Univesity Gujarat IndiaDepartment of Pediatric Cardiac Surgery, Bhanubhai and Madhuben Patel Cardiac Centre Shree Krishna Hospital, Bhaikaka University Karamsad Gujarat IndiaDepartment of Pediatric Cardiac Intensive Care, Bhanubhai and Madhuben Patel Cardiac Centre, Shree Krishna Hospital Bhaikaka University Karamsad Gujarat IndiaDepartment of Perfusion Technology, Bhanubhai and Madhuben Patel Cardiac Centre Shree Krishna Hospital, Bhaikaka Univesity Gujarat IndiaDepartment of Internal Medicine Dev Medical Hospital Vadodara Gujarat IndiaBiostatistician, Central Research Services Bhaikaka University Karamsad Gujarat IndiaABSTRACT Background and Aims Innovative advancements in cardiopulmonary bypass (CPB) configurations, such as surface coating, blood filtration, and miniaturization, aim to reduce gaseous microemboli (GME) that contribute to embolic organ damage, particularly neurological dysfunction. Arterial line filters are effective in mitigating embolism risk. Neurological complications post‐cardiac surgery can result from reduced cerebral blood flow, embolic materials, and other factors, including anesthesia. This study evaluates the impact of integrated arterial filter oxygenator (IAF‐Oxy.) versus external arterial filters (EAF) on clinical outcomes in pediatric patients undergoing surgery for congenital heart disease (CHD). Methods This prospective randomized controlled trial included 100 pediatric patients undergoing cardiac surgery under CPB. Patients were randomized into two groups: Group A included external arterial filters (EAF) with membrane oxygenators such as Capiox Baby RX 05 and others, while Group B included integrated arterial filters (IAF) with oxygenators like Capiox Baby FX 05. The outcomes were neurological function, mechanical ventilation time (hours), intensive care unit stay (hours), and hospital stay (days). Results Group B demonstrated significantly lower mean aortic cross‐clamp (70.2 ± 38.5 vs. 88.0 ± 49.7 min; p = 0.04) and CPB times (104 ± 48.1 vs. 128 ± 66 min; p = 0.03). Postoperative FOUR scores were identical (16 out of 16) in both groups. Median ventilation time (26.5 [24.25–125.25] hours in Group A vs. 25.0 [12.0–50.0] hours in Group B; p = 0.258), CSICU stay (120.0 [72.0–216.0] hours in Group A vs. 108.0 [72.0–162.0] hours in Group B; p = 0.358), and hospital stay (13 ± 11 days in Group A vs. 10 ± 5 days in Group B; p = 0.138) were comparable between groups. Conclusion Integrated arterial filter oxygenator may serve as an alternative to external arterial filters, potentially reducing gaseous microemboli. IAF‐Oxy. could improve clinical outcomes, reduce CSICU and hospital stays, and enhance care for pediatric congenital heart disease (CHD) patients.https://doi.org/10.1002/hsr2.70741arterial filtercapioxcardiac surgerycardiopulmonary bypasscognitive functionsgaseous microemboli |
| spellingShingle | Vishal Vinayak Bhende Mathangi Krishnakumar Dushyantkumar Mukundbhai Parmar Arunkumar Ghanshyambhai Rudakiya Tanishq Shashikant Sharma Amit Kumar Paresh Dilip Nerurkar Saptak Piyush Mankad Mamta Roshan Patel Evaluation of Integrated Arterial Filter Oxygenator vs. External Arterial Filters on Clinical Outcomes and Neurocognitive Function in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Trial (RCT) Health Science Reports arterial filter capiox cardiac surgery cardiopulmonary bypass cognitive functions gaseous microemboli |
| title | Evaluation of Integrated Arterial Filter Oxygenator vs. External Arterial Filters on Clinical Outcomes and Neurocognitive Function in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Trial (RCT) |
| title_full | Evaluation of Integrated Arterial Filter Oxygenator vs. External Arterial Filters on Clinical Outcomes and Neurocognitive Function in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Trial (RCT) |
| title_fullStr | Evaluation of Integrated Arterial Filter Oxygenator vs. External Arterial Filters on Clinical Outcomes and Neurocognitive Function in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Trial (RCT) |
| title_full_unstemmed | Evaluation of Integrated Arterial Filter Oxygenator vs. External Arterial Filters on Clinical Outcomes and Neurocognitive Function in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Trial (RCT) |
| title_short | Evaluation of Integrated Arterial Filter Oxygenator vs. External Arterial Filters on Clinical Outcomes and Neurocognitive Function in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Trial (RCT) |
| title_sort | evaluation of integrated arterial filter oxygenator vs external arterial filters on clinical outcomes and neurocognitive function in pediatric cardiac surgery a prospective randomized controlled trial rct |
| topic | arterial filter capiox cardiac surgery cardiopulmonary bypass cognitive functions gaseous microemboli |
| url | https://doi.org/10.1002/hsr2.70741 |
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