Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial
IMPORTANCE: Prone positioning may improve outcomes in patients with severe acute respiratory distress syndrome (ARDS), but it is unknown whether prone positioning improves clinical outcomes among patients with ARDS who are undergoing venovenous extracorporeal membrane oxygenation (VV-ECMO) compared...
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| Veröffentlicht in: | JAMA : the journal of the American Medical Association 2023-12, Vol.330 (24), p.2343-2353 |
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| creator | Schmidt, Matthieu Hajage, David Lebreton, Guillaume Dres, Martin Guervilly, Christophe Richard, Jean Christophe Sonneville, Romain Winiszewski, Hadrien Muller, Gregoire Beduneau, Gaëtan Mercier, Emmanuelle Roze, Hadrien Lesouhaitier, Mathieu Terzi, Nicolas Thille, Arnaud W Laurent, Isaura Kimmoun, Antoine Combes, Alain |
| description | IMPORTANCE: Prone positioning may improve outcomes in patients with severe acute respiratory distress syndrome (ARDS), but it is unknown whether prone positioning improves clinical outcomes among patients with ARDS who are undergoing venovenous extracorporeal membrane oxygenation (VV-ECMO) compared with supine positioning. OBJECTIVE: To test whether prone positioning vs supine positioning decreases the time to successful ECMO weaning in patients with severe ARDS supported by VV-ECMO. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of patients with severe ARDS undergoing VV-ECMO for less than 48 hours at 14 intensive care units (ICUs) in France between March 3, 2021, and December 7, 2021. INTERVENTIONS: Patients were randomized 1:1 to prone positioning (at least 4 sessions of 16 hours) (n = 86) or to supine positioning (n = 84). MAIN OUTCOMES AND MEASURES: The primary outcome was time to successful ECMO weaning within 60 days following randomization. Secondary outcomes included ECMO and mechanical ventilation–free days, ICU and hospital length of stay, skin pressure injury, serious adverse events, and all-cause mortality at 90-day follow-up. RESULTS: Among 170 randomized patients (median age, 51 [IQR, 43-59] years; n = 60 women [35%]), median respiratory system compliance was 15.0 (IQR, 10.7-20.6) mL/cm H2O; 159 patients (94%) had COVID-19–related ARDS; and 164 (96%) were in prone position before ECMO initiation. Within 60 days of enrollment, 38 of 86 patients (44%) had successful ECMO weaning in the prone ECMO group compared with 37 of 84 (44%) in the supine ECMO group (risk difference, 0.1% [95% CI, −14.9% to 15.2%]; subdistribution hazard ratio, 1.11 [95% CI, 0.71-1.75]; P = .64). Within 90 days, no significant difference was observed in ECMO duration (28 vs 32 days; difference, −4.9 [95% CI, −11.2 to 1.5] days; P = .13), ICU length of stay, or 90-day mortality (51% vs 48%; risk difference, 3.5% [95% CI, −12.7% to 19.7%]; P = .62). No serious adverse events were reported during the prone position procedure. CONCLUSIONS AND RELEVANCE: Among patients with severe ARDS supported by VV-ECMO, prone positioning compared with supine positioning did not significantly reduce time to successful weaning of ECMO. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04607551 |
| doi_str_mv | 10.1001/jama.2023.24491 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2896804495</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ama_id>2812529</ama_id><sourcerecordid>2896804495</sourcerecordid><originalsourceid>FETCH-LOGICAL-a298t-f41b7ad71b3d0bd77d5d4c9771eb1bf058b447bb553dedb0696bc8d680ae7d833</originalsourceid><addsrcrecordid>eNpdkU1vEzEQhi1ERUPhjMQBWeLCZVN_rGObW5UGqNSSKA3iaNlrp3W0awd7F7Xc-Od4SdtDfRlLfubVeB4A3mE0xQjh053u9JQgQqekriV-ASaYUVFRJsVLMEFIiorXoj4Gr3PeoXIw5a_AMRWICirZBPxdpRgcXMXsex-DDzfwfEhjWdz1STcx7WNyuoVXrjNJF3R5d3_jgh5p6ANclZsLfYY_fX8Lr91vlxw8W59ff4ab2xK8Xn5fzK-WcK2DjZ3_4yyctz74pmRuktftG3C01W12bx_qCfjxZbGZf6sul18v5meXlSZS9NW2xoZry7GhFhnLuWW2biTn2BlstogJU9fcGMaoddagmZyZRtiZQNpxKyg9AZ8OufsUfw0u96rzuXFtWz4Vh6yIkAUuW2QF_fgM3cUhhTKdIhJThsr2eKFOD1STYs7JbdU--U6ne4WRGu2o0Y4a7aj_dkrHh4fcwXTOPvGPOgrw_gCMjY-vRGDCiKT_AL_xk_k</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2913500387</pqid></control><display><type>article</type><title>Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial</title><source>MEDLINE</source><source>American Medical Association Journals</source><creator>Schmidt, Matthieu ; Hajage, David ; Lebreton, Guillaume ; Dres, Martin ; Guervilly, Christophe ; Richard, Jean Christophe ; Sonneville, Romain ; Winiszewski, Hadrien ; Muller, Gregoire ; Beduneau, Gaëtan ; Mercier, Emmanuelle ; Roze, Hadrien ; Lesouhaitier, Mathieu ; Terzi, Nicolas ; Thille, Arnaud W ; Laurent, Isaura ; Kimmoun, Antoine ; Combes, Alain</creator><creatorcontrib>Schmidt, Matthieu ; Hajage, David ; Lebreton, Guillaume ; Dres, Martin ; Guervilly, Christophe ; Richard, Jean Christophe ; Sonneville, Romain ; Winiszewski, Hadrien ; Muller, Gregoire ; Beduneau, Gaëtan ; Mercier, Emmanuelle ; Roze, Hadrien ; Lesouhaitier, Mathieu ; Terzi, Nicolas ; Thille, Arnaud W ; Laurent, Isaura ; Kimmoun, Antoine ; Combes, Alain ; PRONECMO Investigators, the REVA Network, and the International ECMO Network (ECMONet)</creatorcontrib><description>IMPORTANCE: Prone positioning may improve outcomes in patients with severe acute respiratory distress syndrome (ARDS), but it is unknown whether prone positioning improves clinical outcomes among patients with ARDS who are undergoing venovenous extracorporeal membrane oxygenation (VV-ECMO) compared with supine positioning. OBJECTIVE: To test whether prone positioning vs supine positioning decreases the time to successful ECMO weaning in patients with severe ARDS supported by VV-ECMO. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of patients with severe ARDS undergoing VV-ECMO for less than 48 hours at 14 intensive care units (ICUs) in France between March 3, 2021, and December 7, 2021. INTERVENTIONS: Patients were randomized 1:1 to prone positioning (at least 4 sessions of 16 hours) (n = 86) or to supine positioning (n = 84). MAIN OUTCOMES AND MEASURES: The primary outcome was time to successful ECMO weaning within 60 days following randomization. Secondary outcomes included ECMO and mechanical ventilation–free days, ICU and hospital length of stay, skin pressure injury, serious adverse events, and all-cause mortality at 90-day follow-up. RESULTS: Among 170 randomized patients (median age, 51 [IQR, 43-59] years; n = 60 women [35%]), median respiratory system compliance was 15.0 (IQR, 10.7-20.6) mL/cm H2O; 159 patients (94%) had COVID-19–related ARDS; and 164 (96%) were in prone position before ECMO initiation. Within 60 days of enrollment, 38 of 86 patients (44%) had successful ECMO weaning in the prone ECMO group compared with 37 of 84 (44%) in the supine ECMO group (risk difference, 0.1% [95% CI, −14.9% to 15.2%]; subdistribution hazard ratio, 1.11 [95% CI, 0.71-1.75]; P = .64). Within 90 days, no significant difference was observed in ECMO duration (28 vs 32 days; difference, −4.9 [95% CI, −11.2 to 1.5] days; P = .13), ICU length of stay, or 90-day mortality (51% vs 48%; risk difference, 3.5% [95% CI, −12.7% to 19.7%]; P = .62). No serious adverse events were reported during the prone position procedure. CONCLUSIONS AND RELEVANCE: Among patients with severe ARDS supported by VV-ECMO, prone positioning compared with supine positioning did not significantly reduce time to successful weaning of ECMO. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04607551</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.2023.24491</identifier><identifier>PMID: 38038395</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Adverse events ; Clinical trials ; COVID-19 ; Extracorporeal membrane oxygenation ; Extracorporeal Membrane Oxygenation - methods ; Female ; Hospitals ; Humans ; Intensive Care Units ; Length of stay ; Mechanical ventilation ; Membranes ; Middle Aged ; Mortality ; Oxygenation ; Patient positioning ; Patients ; Prone Position ; Randomization ; Respiration, Artificial - methods ; Respiratory distress syndrome ; Respiratory Distress Syndrome - mortality ; Respiratory Distress Syndrome - therapy ; Respiratory system ; Weaning</subject><ispartof>JAMA : the journal of the American Medical Association, 2023-12, Vol.330 (24), p.2343-2353</ispartof><rights>Copyright American Medical Association Dec 26, 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a298t-f41b7ad71b3d0bd77d5d4c9771eb1bf058b447bb553dedb0696bc8d680ae7d833</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.2023.24491$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2023.24491$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,314,776,780,3327,27901,27902,76232,76235</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38038395$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schmidt, Matthieu</creatorcontrib><creatorcontrib>Hajage, David</creatorcontrib><creatorcontrib>Lebreton, Guillaume</creatorcontrib><creatorcontrib>Dres, Martin</creatorcontrib><creatorcontrib>Guervilly, Christophe</creatorcontrib><creatorcontrib>Richard, Jean Christophe</creatorcontrib><creatorcontrib>Sonneville, Romain</creatorcontrib><creatorcontrib>Winiszewski, Hadrien</creatorcontrib><creatorcontrib>Muller, Gregoire</creatorcontrib><creatorcontrib>Beduneau, Gaëtan</creatorcontrib><creatorcontrib>Mercier, Emmanuelle</creatorcontrib><creatorcontrib>Roze, Hadrien</creatorcontrib><creatorcontrib>Lesouhaitier, Mathieu</creatorcontrib><creatorcontrib>Terzi, Nicolas</creatorcontrib><creatorcontrib>Thille, Arnaud W</creatorcontrib><creatorcontrib>Laurent, Isaura</creatorcontrib><creatorcontrib>Kimmoun, Antoine</creatorcontrib><creatorcontrib>Combes, Alain</creatorcontrib><creatorcontrib>PRONECMO Investigators, the REVA Network, and the International ECMO Network (ECMONet)</creatorcontrib><title>Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>IMPORTANCE: Prone positioning may improve outcomes in patients with severe acute respiratory distress syndrome (ARDS), but it is unknown whether prone positioning improves clinical outcomes among patients with ARDS who are undergoing venovenous extracorporeal membrane oxygenation (VV-ECMO) compared with supine positioning. OBJECTIVE: To test whether prone positioning vs supine positioning decreases the time to successful ECMO weaning in patients with severe ARDS supported by VV-ECMO. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of patients with severe ARDS undergoing VV-ECMO for less than 48 hours at 14 intensive care units (ICUs) in France between March 3, 2021, and December 7, 2021. INTERVENTIONS: Patients were randomized 1:1 to prone positioning (at least 4 sessions of 16 hours) (n = 86) or to supine positioning (n = 84). MAIN OUTCOMES AND MEASURES: The primary outcome was time to successful ECMO weaning within 60 days following randomization. Secondary outcomes included ECMO and mechanical ventilation–free days, ICU and hospital length of stay, skin pressure injury, serious adverse events, and all-cause mortality at 90-day follow-up. RESULTS: Among 170 randomized patients (median age, 51 [IQR, 43-59] years; n = 60 women [35%]), median respiratory system compliance was 15.0 (IQR, 10.7-20.6) mL/cm H2O; 159 patients (94%) had COVID-19–related ARDS; and 164 (96%) were in prone position before ECMO initiation. Within 60 days of enrollment, 38 of 86 patients (44%) had successful ECMO weaning in the prone ECMO group compared with 37 of 84 (44%) in the supine ECMO group (risk difference, 0.1% [95% CI, −14.9% to 15.2%]; subdistribution hazard ratio, 1.11 [95% CI, 0.71-1.75]; P = .64). Within 90 days, no significant difference was observed in ECMO duration (28 vs 32 days; difference, −4.9 [95% CI, −11.2 to 1.5] days; P = .13), ICU length of stay, or 90-day mortality (51% vs 48%; risk difference, 3.5% [95% CI, −12.7% to 19.7%]; P = .62). No serious adverse events were reported during the prone position procedure. CONCLUSIONS AND RELEVANCE: Among patients with severe ARDS supported by VV-ECMO, prone positioning compared with supine positioning did not significantly reduce time to successful weaning of ECMO. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04607551</description><subject>Adverse events</subject><subject>Clinical trials</subject><subject>COVID-19</subject><subject>Extracorporeal membrane oxygenation</subject><subject>Extracorporeal Membrane Oxygenation - methods</subject><subject>Female</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Intensive Care Units</subject><subject>Length of stay</subject><subject>Mechanical ventilation</subject><subject>Membranes</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Oxygenation</subject><subject>Patient positioning</subject><subject>Patients</subject><subject>Prone Position</subject><subject>Randomization</subject><subject>Respiration, Artificial - methods</subject><subject>Respiratory distress syndrome</subject><subject>Respiratory Distress Syndrome - mortality</subject><subject>Respiratory Distress Syndrome - therapy</subject><subject>Respiratory system</subject><subject>Weaning</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkU1vEzEQhi1ERUPhjMQBWeLCZVN_rGObW5UGqNSSKA3iaNlrp3W0awd7F7Xc-Od4SdtDfRlLfubVeB4A3mE0xQjh053u9JQgQqekriV-ASaYUVFRJsVLMEFIiorXoj4Gr3PeoXIw5a_AMRWICirZBPxdpRgcXMXsex-DDzfwfEhjWdz1STcx7WNyuoVXrjNJF3R5d3_jgh5p6ANclZsLfYY_fX8Lr91vlxw8W59ff4ab2xK8Xn5fzK-WcK2DjZ3_4yyctz74pmRuktftG3C01W12bx_qCfjxZbGZf6sul18v5meXlSZS9NW2xoZry7GhFhnLuWW2biTn2BlstogJU9fcGMaoddagmZyZRtiZQNpxKyg9AZ8OufsUfw0u96rzuXFtWz4Vh6yIkAUuW2QF_fgM3cUhhTKdIhJThsr2eKFOD1STYs7JbdU--U6ne4WRGu2o0Y4a7aj_dkrHh4fcwXTOPvGPOgrw_gCMjY-vRGDCiKT_AL_xk_k</recordid><startdate>20231226</startdate><enddate>20231226</enddate><creator>Schmidt, Matthieu</creator><creator>Hajage, David</creator><creator>Lebreton, Guillaume</creator><creator>Dres, Martin</creator><creator>Guervilly, Christophe</creator><creator>Richard, Jean Christophe</creator><creator>Sonneville, Romain</creator><creator>Winiszewski, Hadrien</creator><creator>Muller, Gregoire</creator><creator>Beduneau, Gaëtan</creator><creator>Mercier, Emmanuelle</creator><creator>Roze, Hadrien</creator><creator>Lesouhaitier, Mathieu</creator><creator>Terzi, Nicolas</creator><creator>Thille, Arnaud W</creator><creator>Laurent, Isaura</creator><creator>Kimmoun, Antoine</creator><creator>Combes, Alain</creator><general>American Medical Association</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>20231226</creationdate><title>Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial</title><author>Schmidt, Matthieu ; Hajage, David ; Lebreton, Guillaume ; Dres, Martin ; Guervilly, Christophe ; Richard, Jean Christophe ; Sonneville, Romain ; Winiszewski, Hadrien ; Muller, Gregoire ; Beduneau, Gaëtan ; Mercier, Emmanuelle ; Roze, Hadrien ; Lesouhaitier, Mathieu ; Terzi, Nicolas ; Thille, Arnaud W ; Laurent, Isaura ; Kimmoun, Antoine ; Combes, Alain</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a298t-f41b7ad71b3d0bd77d5d4c9771eb1bf058b447bb553dedb0696bc8d680ae7d833</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adverse events</topic><topic>Clinical trials</topic><topic>COVID-19</topic><topic>Extracorporeal membrane oxygenation</topic><topic>Extracorporeal Membrane Oxygenation - methods</topic><topic>Female</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Intensive Care Units</topic><topic>Length of stay</topic><topic>Mechanical ventilation</topic><topic>Membranes</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Oxygenation</topic><topic>Patient positioning</topic><topic>Patients</topic><topic>Prone Position</topic><topic>Randomization</topic><topic>Respiration, Artificial - methods</topic><topic>Respiratory distress syndrome</topic><topic>Respiratory Distress Syndrome - mortality</topic><topic>Respiratory Distress Syndrome - therapy</topic><topic>Respiratory system</topic><topic>Weaning</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schmidt, Matthieu</creatorcontrib><creatorcontrib>Hajage, David</creatorcontrib><creatorcontrib>Lebreton, Guillaume</creatorcontrib><creatorcontrib>Dres, Martin</creatorcontrib><creatorcontrib>Guervilly, Christophe</creatorcontrib><creatorcontrib>Richard, Jean Christophe</creatorcontrib><creatorcontrib>Sonneville, Romain</creatorcontrib><creatorcontrib>Winiszewski, Hadrien</creatorcontrib><creatorcontrib>Muller, Gregoire</creatorcontrib><creatorcontrib>Beduneau, Gaëtan</creatorcontrib><creatorcontrib>Mercier, Emmanuelle</creatorcontrib><creatorcontrib>Roze, Hadrien</creatorcontrib><creatorcontrib>Lesouhaitier, Mathieu</creatorcontrib><creatorcontrib>Terzi, Nicolas</creatorcontrib><creatorcontrib>Thille, Arnaud W</creatorcontrib><creatorcontrib>Laurent, Isaura</creatorcontrib><creatorcontrib>Kimmoun, Antoine</creatorcontrib><creatorcontrib>Combes, Alain</creatorcontrib><creatorcontrib>PRONECMO Investigators, the REVA Network, and the International ECMO Network (ECMONet)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schmidt, Matthieu</au><au>Hajage, David</au><au>Lebreton, Guillaume</au><au>Dres, Martin</au><au>Guervilly, Christophe</au><au>Richard, Jean Christophe</au><au>Sonneville, Romain</au><au>Winiszewski, Hadrien</au><au>Muller, Gregoire</au><au>Beduneau, Gaëtan</au><au>Mercier, Emmanuelle</au><au>Roze, Hadrien</au><au>Lesouhaitier, Mathieu</au><au>Terzi, Nicolas</au><au>Thille, Arnaud W</au><au>Laurent, Isaura</au><au>Kimmoun, Antoine</au><au>Combes, Alain</au><aucorp>PRONECMO Investigators, the REVA Network, and the International ECMO Network (ECMONet)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2023-12-26</date><risdate>2023</risdate><volume>330</volume><issue>24</issue><spage>2343</spage><epage>2353</epage><pages>2343-2353</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><abstract>IMPORTANCE: Prone positioning may improve outcomes in patients with severe acute respiratory distress syndrome (ARDS), but it is unknown whether prone positioning improves clinical outcomes among patients with ARDS who are undergoing venovenous extracorporeal membrane oxygenation (VV-ECMO) compared with supine positioning. OBJECTIVE: To test whether prone positioning vs supine positioning decreases the time to successful ECMO weaning in patients with severe ARDS supported by VV-ECMO. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial of patients with severe ARDS undergoing VV-ECMO for less than 48 hours at 14 intensive care units (ICUs) in France between March 3, 2021, and December 7, 2021. INTERVENTIONS: Patients were randomized 1:1 to prone positioning (at least 4 sessions of 16 hours) (n = 86) or to supine positioning (n = 84). MAIN OUTCOMES AND MEASURES: The primary outcome was time to successful ECMO weaning within 60 days following randomization. Secondary outcomes included ECMO and mechanical ventilation–free days, ICU and hospital length of stay, skin pressure injury, serious adverse events, and all-cause mortality at 90-day follow-up. RESULTS: Among 170 randomized patients (median age, 51 [IQR, 43-59] years; n = 60 women [35%]), median respiratory system compliance was 15.0 (IQR, 10.7-20.6) mL/cm H2O; 159 patients (94%) had COVID-19–related ARDS; and 164 (96%) were in prone position before ECMO initiation. Within 60 days of enrollment, 38 of 86 patients (44%) had successful ECMO weaning in the prone ECMO group compared with 37 of 84 (44%) in the supine ECMO group (risk difference, 0.1% [95% CI, −14.9% to 15.2%]; subdistribution hazard ratio, 1.11 [95% CI, 0.71-1.75]; P = .64). Within 90 days, no significant difference was observed in ECMO duration (28 vs 32 days; difference, −4.9 [95% CI, −11.2 to 1.5] days; P = .13), ICU length of stay, or 90-day mortality (51% vs 48%; risk difference, 3.5% [95% CI, −12.7% to 19.7%]; P = .62). No serious adverse events were reported during the prone position procedure. CONCLUSIONS AND RELEVANCE: Among patients with severe ARDS supported by VV-ECMO, prone positioning compared with supine positioning did not significantly reduce time to successful weaning of ECMO. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04607551</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>38038395</pmid><doi>10.1001/jama.2023.24491</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0098-7484 |
| ispartof | JAMA : the journal of the American Medical Association, 2023-12, Vol.330 (24), p.2343-2353 |
| issn | 0098-7484 1538-3598 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2896804495 |
| source | MEDLINE; American Medical Association Journals |
| subjects | Adverse events Clinical trials COVID-19 Extracorporeal membrane oxygenation Extracorporeal Membrane Oxygenation - methods Female Hospitals Humans Intensive Care Units Length of stay Mechanical ventilation Membranes Middle Aged Mortality Oxygenation Patient positioning Patients Prone Position Randomization Respiration, Artificial - methods Respiratory distress syndrome Respiratory Distress Syndrome - mortality Respiratory Distress Syndrome - therapy Respiratory system Weaning |
| title | Prone Positioning During Extracorporeal Membrane Oxygenation in Patients With Severe ARDS: The PRONECMO Randomized Clinical Trial |
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