Clinical evaluation of the novel Capiox NX19 adult oxygenator–a multicenter study

Introduction The novel Capiox NX19 adult oxygenator is, compared to its predecessors, improved with enhanced air removal technology, a polymer heat exchanger and smaller, innovative hollow fibers resulting in a surface area reduction and a lower priming volume. The aim of this study was to evaluate...

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Veröffentlicht in:Perfusion 2023-05, Vol.38 (4), p.734-739
Hauptverfasser: Hendrix, Rik H J, Debeuckelaere, Gerdy, Degezelle, Karlien, Lenaerts, Lieven, Verbelen, Tom, Weerwind, Patrick W
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container_end_page 739
container_issue 4
container_start_page 734
container_title Perfusion
container_volume 38
creator Hendrix, Rik H J
Debeuckelaere, Gerdy
Degezelle, Karlien
Lenaerts, Lieven
Verbelen, Tom
Weerwind, Patrick W
description Introduction The novel Capiox NX19 adult oxygenator is, compared to its predecessors, improved with enhanced air removal technology, a polymer heat exchanger and smaller, innovative hollow fibers resulting in a surface area reduction and a lower priming volume. The aim of this study was to evaluate the NX19 oxygenator performance in a clinical setting. Methods A prospective multicenter study was performed involving three large European university hospitals. The Capiox NX19 (n = 150) performance was assessed during adult cardiopulmonary bypass and involved gaseous microemboli handling and gas transfer efficiency. The heat exchanger performance was evaluated separately in vitro. Results The heat exchanger performance factors were 0.80 ± 0.03 and 0.58 ± 0.04 at pump flow rates of 3 L/min and 6 L/min, respectively. After priming, residual post-oxygenator gaseous microemboli count and volume were decreased by 91% and 93.7%, respectively. The gas compartment pressure was 6.0 ± 2.5 mmHg, while the O2 transfer was 69 ± 30 mL/min/m2 and the CO2 transfer 73 ± 34 mL/min/m2. The O2 gradient was 44 ± 19 mmHg/LPM and the O2 diffusing capacity 0.38 ± 0.14 mL/min/mmHg. The shunt fraction was 0.19 ± 0.13, whereas oxygenator resistance and shear stress were 10.5 ± 3.7 mmHg/LPM and 5.1 ± 3.1 dyn/cm2, respectively. Conclusion This multicenter study displayed good clinical safety and performance of the NX19 oxygenator.
doi_str_mv 10.1177/02676591221078942
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The aim of this study was to evaluate the NX19 oxygenator performance in a clinical setting. Methods A prospective multicenter study was performed involving three large European university hospitals. The Capiox NX19 (n = 150) performance was assessed during adult cardiopulmonary bypass and involved gaseous microemboli handling and gas transfer efficiency. The heat exchanger performance was evaluated separately in vitro. Results The heat exchanger performance factors were 0.80 ± 0.03 and 0.58 ± 0.04 at pump flow rates of 3 L/min and 6 L/min, respectively. After priming, residual post-oxygenator gaseous microemboli count and volume were decreased by 91% and 93.7%, respectively. The gas compartment pressure was 6.0 ± 2.5 mmHg, while the O2 transfer was 69 ± 30 mL/min/m2 and the CO2 transfer 73 ± 34 mL/min/m2. The O2 gradient was 44 ± 19 mmHg/LPM and the O2 diffusing capacity 0.38 ± 0.14 mL/min/mmHg. The shunt fraction was 0.19 ± 0.13, whereas oxygenator resistance and shear stress were 10.5 ± 3.7 mmHg/LPM and 5.1 ± 3.1 dyn/cm2, respectively. Conclusion This multicenter study displayed good clinical safety and performance of the NX19 oxygenator.</description><identifier>ISSN: 0267-6591</identifier><identifier>EISSN: 1477-111X</identifier><identifier>DOI: 10.1177/02676591221078942</identifier><identifier>PMID: 35348392</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Adult ; Carbon dioxide ; Cardiopulmonary Bypass ; Equipment Design ; Extracorporeal Membrane Oxygenation ; Flow velocity ; Gases ; Heart surgery ; Heat ; Heat exchangers ; Humans ; Original Papers ; Oxygenators, Membrane ; Performance evaluation ; Polymers ; Priming ; Prospective Studies ; Shear stress ; Surgical apparatus &amp; instruments</subject><ispartof>Perfusion, 2023-05, Vol.38 (4), p.734-739</ispartof><rights>The Author(s) 2022</rights><rights>The Author(s) 2022 2022 SAGE Publications</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c467t-595da3876e9160889715fb4312bdb7086cf572ba4fdb32ba997c36f44ec8be063</citedby><cites>FETCH-LOGICAL-c467t-595da3876e9160889715fb4312bdb7086cf572ba4fdb32ba997c36f44ec8be063</cites><orcidid>0000-0001-6733-6287</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/02676591221078942$$EPDF$$P50$$Gsage$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/02676591221078942$$EHTML$$P50$$Gsage$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,21798,27901,27902,43597,43598</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35348392$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hendrix, Rik H J</creatorcontrib><creatorcontrib>Debeuckelaere, Gerdy</creatorcontrib><creatorcontrib>Degezelle, Karlien</creatorcontrib><creatorcontrib>Lenaerts, Lieven</creatorcontrib><creatorcontrib>Verbelen, Tom</creatorcontrib><creatorcontrib>Weerwind, Patrick W</creatorcontrib><title>Clinical evaluation of the novel Capiox NX19 adult oxygenator–a multicenter study</title><title>Perfusion</title><addtitle>Perfusion</addtitle><description>Introduction The novel Capiox NX19 adult oxygenator is, compared to its predecessors, improved with enhanced air removal technology, a polymer heat exchanger and smaller, innovative hollow fibers resulting in a surface area reduction and a lower priming volume. The aim of this study was to evaluate the NX19 oxygenator performance in a clinical setting. Methods A prospective multicenter study was performed involving three large European university hospitals. The Capiox NX19 (n = 150) performance was assessed during adult cardiopulmonary bypass and involved gaseous microemboli handling and gas transfer efficiency. The heat exchanger performance was evaluated separately in vitro. Results The heat exchanger performance factors were 0.80 ± 0.03 and 0.58 ± 0.04 at pump flow rates of 3 L/min and 6 L/min, respectively. After priming, residual post-oxygenator gaseous microemboli count and volume were decreased by 91% and 93.7%, respectively. The gas compartment pressure was 6.0 ± 2.5 mmHg, while the O2 transfer was 69 ± 30 mL/min/m2 and the CO2 transfer 73 ± 34 mL/min/m2. The O2 gradient was 44 ± 19 mmHg/LPM and the O2 diffusing capacity 0.38 ± 0.14 mL/min/mmHg. The shunt fraction was 0.19 ± 0.13, whereas oxygenator resistance and shear stress were 10.5 ± 3.7 mmHg/LPM and 5.1 ± 3.1 dyn/cm2, respectively. 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Perfusion</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hendrix, Rik H J</au><au>Debeuckelaere, Gerdy</au><au>Degezelle, Karlien</au><au>Lenaerts, Lieven</au><au>Verbelen, Tom</au><au>Weerwind, Patrick W</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical evaluation of the novel Capiox NX19 adult oxygenator–a multicenter study</atitle><jtitle>Perfusion</jtitle><addtitle>Perfusion</addtitle><date>2023-05-01</date><risdate>2023</risdate><volume>38</volume><issue>4</issue><spage>734</spage><epage>739</epage><pages>734-739</pages><issn>0267-6591</issn><eissn>1477-111X</eissn><abstract>Introduction The novel Capiox NX19 adult oxygenator is, compared to its predecessors, improved with enhanced air removal technology, a polymer heat exchanger and smaller, innovative hollow fibers resulting in a surface area reduction and a lower priming volume. The aim of this study was to evaluate the NX19 oxygenator performance in a clinical setting. Methods A prospective multicenter study was performed involving three large European university hospitals. The Capiox NX19 (n = 150) performance was assessed during adult cardiopulmonary bypass and involved gaseous microemboli handling and gas transfer efficiency. The heat exchanger performance was evaluated separately in vitro. Results The heat exchanger performance factors were 0.80 ± 0.03 and 0.58 ± 0.04 at pump flow rates of 3 L/min and 6 L/min, respectively. After priming, residual post-oxygenator gaseous microemboli count and volume were decreased by 91% and 93.7%, respectively. The gas compartment pressure was 6.0 ± 2.5 mmHg, while the O2 transfer was 69 ± 30 mL/min/m2 and the CO2 transfer 73 ± 34 mL/min/m2. The O2 gradient was 44 ± 19 mmHg/LPM and the O2 diffusing capacity 0.38 ± 0.14 mL/min/mmHg. The shunt fraction was 0.19 ± 0.13, whereas oxygenator resistance and shear stress were 10.5 ± 3.7 mmHg/LPM and 5.1 ± 3.1 dyn/cm2, respectively. Conclusion This multicenter study displayed good clinical safety and performance of the NX19 oxygenator.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>35348392</pmid><doi>10.1177/02676591221078942</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0001-6733-6287</orcidid><oa>free_for_read</oa></addata></record>
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subjects Adult
Carbon dioxide
Cardiopulmonary Bypass
Equipment Design
Extracorporeal Membrane Oxygenation
Flow velocity
Gases
Heart surgery
Heat
Heat exchangers
Humans
Original Papers
Oxygenators, Membrane
Performance evaluation
Polymers
Priming
Prospective Studies
Shear stress
Surgical apparatus & instruments
title Clinical evaluation of the novel Capiox NX19 adult oxygenator–a multicenter study
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