Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial

CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days...

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Veröffentlicht in:JAMA : the journal of the American Medical Association 2005-07, Vol.294 (2), p.229-237
Hauptverfasser: Curley, Martha A. Q, Hibberd, Patricia L, Fineman, Lori D, Wypij, David, Shih, Mei-Chiung, Thompson, John E, Grant, Mary Jo C, Barr, Frederick E, Cvijanovich, Natalie Z, Sorce, Lauren, Luckett, Peter M, Matthay, Michael A, Arnold, John H
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container_issue 2
container_start_page 229
container_title JAMA : the journal of the American Medical Association
container_volume 294
creator Curley, Martha A. Q
Hibberd, Patricia L
Fineman, Lori D
Wypij, David
Shih, Mei-Chiung
Thompson, John E
Grant, Mary Jo C
Barr, Frederick E
Cvijanovich, Natalie Z
Sorce, Lauren
Luckett, Peter M
Matthay, Michael A
Arnold, John H
description CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning. DESIGN, SETTING, AND PATIENTS Multicenter, randomized, controlled clinical trial conducted from August 28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs prone positioning. Randomization was concealed and group assignment was not blinded. INTERVENTION Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines. MAIN OUTCOME MEASURE Ventilator-free days to day 28. RESULTS The trial was stopped at the planned interim analysis on the basis of the prespecified futility stopping rule. There were no differences in the number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5] supine vs 15.6 [8.6] prone; mean difference, −0.2 days; 95% CI, −3.6 to 3.2; P = .91). After controlling for age, Pediatric Risk of Mortality III score, direct vs indirect acute lung injury, and mode of mechanical ventilation at enrollment, the adjusted difference in ventilator-free days was 0.3 days (95% CI, −3.0 to 3.5; P = .87). There were no differences in the secondary end points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P>.99), the time to recovery of lung injury (P = .78), organ-failure−free days (P = .88), and cognitive impairment (P = .16) or overall functional health (P = .12) at hospital discharge or on day 28. CONCLUSION Prone positioning does not significantly reduce ventilator-free days or improve other clinical outcomes in pediatric patients with acute lung injury.
doi_str_mv 10.1001/jama.294.2.229
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Q ; Hibberd, Patricia L ; Fineman, Lori D ; Wypij, David ; Shih, Mei-Chiung ; Thompson, John E ; Grant, Mary Jo C ; Barr, Frederick E ; Cvijanovich, Natalie Z ; Sorce, Lauren ; Luckett, Peter M ; Matthay, Michael A ; Arnold, John H</creator><creatorcontrib>Curley, Martha A. Q ; Hibberd, Patricia L ; Fineman, Lori D ; Wypij, David ; Shih, Mei-Chiung ; Thompson, John E ; Grant, Mary Jo C ; Barr, Frederick E ; Cvijanovich, Natalie Z ; Sorce, Lauren ; Luckett, Peter M ; Matthay, Michael A ; Arnold, John H</creatorcontrib><description>CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning. DESIGN, SETTING, AND PATIENTS Multicenter, randomized, controlled clinical trial conducted from August 28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs prone positioning. Randomization was concealed and group assignment was not blinded. INTERVENTION Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines. MAIN OUTCOME MEASURE Ventilator-free days to day 28. RESULTS The trial was stopped at the planned interim analysis on the basis of the prespecified futility stopping rule. There were no differences in the number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5] supine vs 15.6 [8.6] prone; mean difference, −0.2 days; 95% CI, −3.6 to 3.2; P = .91). After controlling for age, Pediatric Risk of Mortality III score, direct vs indirect acute lung injury, and mode of mechanical ventilation at enrollment, the adjusted difference in ventilator-free days was 0.3 days (95% CI, −3.0 to 3.5; P = .87). There were no differences in the secondary end points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P&gt;.99), the time to recovery of lung injury (P = .78), organ-failure−free days (P = .88), and cognitive impairment (P = .16) or overall functional health (P = .12) at hospital discharge or on day 28. CONCLUSION Prone positioning does not significantly reduce ventilator-free days or improve other clinical outcomes in pediatric patients with acute lung injury.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.294.2.229</identifier><identifier>PMID: 16014597</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Adolescent ; Biological and medical sciences ; Child ; Child, Preschool ; Children &amp; youth ; Clinical outcomes ; Effectiveness studies ; Female ; General aspects ; Humans ; Infant ; Infant, Newborn ; Inpatient care ; Intensive Care Units, Pediatric ; Male ; Medical sciences ; Pediatrics ; Prone Position ; Respiration, Artificial ; Respiratory diseases ; Respiratory Distress Syndrome, Adult - therapy ; Respiratory Distress Syndrome, Newborn - therapy ; Supine Position</subject><ispartof>JAMA : the journal of the American Medical Association, 2005-07, Vol.294 (2), p.229-237</ispartof><rights>2005 INIST-CNRS</rights><rights>Copyright American Medical Association Jul 13, 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></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.294.2.229$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.294.2.229$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,230,314,776,780,881,3327,27901,27902,76231,76234</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=16929516$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16014597$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Curley, Martha A. Q</creatorcontrib><creatorcontrib>Hibberd, Patricia L</creatorcontrib><creatorcontrib>Fineman, Lori D</creatorcontrib><creatorcontrib>Wypij, David</creatorcontrib><creatorcontrib>Shih, Mei-Chiung</creatorcontrib><creatorcontrib>Thompson, John E</creatorcontrib><creatorcontrib>Grant, Mary Jo C</creatorcontrib><creatorcontrib>Barr, Frederick E</creatorcontrib><creatorcontrib>Cvijanovich, Natalie Z</creatorcontrib><creatorcontrib>Sorce, Lauren</creatorcontrib><creatorcontrib>Luckett, Peter M</creatorcontrib><creatorcontrib>Matthay, Michael A</creatorcontrib><creatorcontrib>Arnold, John H</creatorcontrib><title>Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning. DESIGN, SETTING, AND PATIENTS Multicenter, randomized, controlled clinical trial conducted from August 28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs prone positioning. Randomization was concealed and group assignment was not blinded. INTERVENTION Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines. MAIN OUTCOME MEASURE Ventilator-free days to day 28. RESULTS The trial was stopped at the planned interim analysis on the basis of the prespecified futility stopping rule. There were no differences in the number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5] supine vs 15.6 [8.6] prone; mean difference, −0.2 days; 95% CI, −3.6 to 3.2; P = .91). After controlling for age, Pediatric Risk of Mortality III score, direct vs indirect acute lung injury, and mode of mechanical ventilation at enrollment, the adjusted difference in ventilator-free days was 0.3 days (95% CI, −3.0 to 3.5; P = .87). There were no differences in the secondary end points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P&gt;.99), the time to recovery of lung injury (P = .78), organ-failure−free days (P = .88), and cognitive impairment (P = .16) or overall functional health (P = .12) at hospital discharge or on day 28. CONCLUSION Prone positioning does not significantly reduce ventilator-free days or improve other clinical outcomes in pediatric patients with acute lung injury.</description><subject>Adolescent</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Children &amp; youth</subject><subject>Clinical outcomes</subject><subject>Effectiveness studies</subject><subject>Female</subject><subject>General aspects</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Inpatient care</subject><subject>Intensive Care Units, Pediatric</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pediatrics</subject><subject>Prone Position</subject><subject>Respiration, Artificial</subject><subject>Respiratory diseases</subject><subject>Respiratory Distress Syndrome, Adult - therapy</subject><subject>Respiratory Distress Syndrome, Newborn - therapy</subject><subject>Supine Position</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkdFrFDEQxoMo9qy-Cr5IKOjbnplks7vxoXAcVQsHLVLxcZlLsr0c2aQmu0L96430LG1DICHzmy_fzBDyFtgSGINPexxxyVW95EvO1TOyACm6SkjVPScLxlRXtXVXH5FXOe9ZWSDal-QIGga1VO2CpLNhsHqicaCXKQZLL2N2k4vBhWsaA117F5xGTy_mScfRZurK4855k2ygP920oys9T5Zu5pJwHvZzuv1MV_Q7BhNH98cauo5hStH7cr1KDv1r8mJAn-2bw3lMfnw5u1p_qzYXX8_Xq02FQqipGramNpIxKYUFLtBIteXadGULpUVTCmASOWJrwTTciqYRMPBawWAVa2pxTE7vdG_m7WiNtsUG-v4muRHTbR_R9Y8jwe366_i7L7-1TDRF4ONBIMVfs81TP7qsrfcYbJxz33RMQGlxAU-egPs4p1CK6zmUjqsO2gK9f2jn3sf_WRTgwwHAXDo-JAza5Qec4krCP1vv7rgy-vsoZwBdK_4C_iihEw</recordid><startdate>20050713</startdate><enddate>20050713</enddate><creator>Curley, Martha A. 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Q ; Hibberd, Patricia L ; Fineman, Lori D ; Wypij, David ; Shih, Mei-Chiung ; Thompson, John E ; Grant, Mary Jo C ; Barr, Frederick E ; Cvijanovich, Natalie Z ; Sorce, Lauren ; Luckett, Peter M ; Matthay, Michael A ; Arnold, John H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a339t-fbd4d500553e123ad59b2cd8cd839c3614505a2aa7e1d62e36631f2491fe90643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adolescent</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children &amp; youth</topic><topic>Clinical outcomes</topic><topic>Effectiveness studies</topic><topic>Female</topic><topic>General aspects</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Inpatient care</topic><topic>Intensive Care Units, Pediatric</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Pediatrics</topic><topic>Prone Position</topic><topic>Respiration, Artificial</topic><topic>Respiratory diseases</topic><topic>Respiratory Distress Syndrome, Adult - therapy</topic><topic>Respiratory Distress Syndrome, Newborn - therapy</topic><topic>Supine Position</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Curley, Martha A. Q</creatorcontrib><creatorcontrib>Hibberd, Patricia L</creatorcontrib><creatorcontrib>Fineman, Lori D</creatorcontrib><creatorcontrib>Wypij, David</creatorcontrib><creatorcontrib>Shih, Mei-Chiung</creatorcontrib><creatorcontrib>Thompson, John E</creatorcontrib><creatorcontrib>Grant, Mary Jo C</creatorcontrib><creatorcontrib>Barr, Frederick E</creatorcontrib><creatorcontrib>Cvijanovich, Natalie Z</creatorcontrib><creatorcontrib>Sorce, Lauren</creatorcontrib><creatorcontrib>Luckett, Peter M</creatorcontrib><creatorcontrib>Matthay, Michael A</creatorcontrib><creatorcontrib>Arnold, John H</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium &amp; 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 &amp; Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Curley, Martha A. Q</au><au>Hibberd, Patricia L</au><au>Fineman, Lori D</au><au>Wypij, David</au><au>Shih, Mei-Chiung</au><au>Thompson, John E</au><au>Grant, Mary Jo C</au><au>Barr, Frederick E</au><au>Cvijanovich, Natalie Z</au><au>Sorce, Lauren</au><au>Luckett, Peter M</au><au>Matthay, Michael A</au><au>Arnold, John H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>2005-07-13</date><risdate>2005</risdate><volume>294</volume><issue>2</issue><spage>229</spage><epage>237</epage><pages>229-237</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT In uncontrolled clinical studies, prone positioning appeared to be safe and to improve oxygenation in pediatric patients with acute lung injury. However, the effect of prone positioning on clinical outcomes in children is not known. OBJECTIVE To test the hypothesis that at the end of 28 days infants and children with acute lung injury treated with prone positioning would have more ventilator-free days than those treated with supine positioning. DESIGN, SETTING, AND PATIENTS Multicenter, randomized, controlled clinical trial conducted from August 28, 2001, to April 23, 2004, of 102 pediatric patients from 7 US pediatric intensive care units aged 2 weeks to 18 years who were treated with supine vs prone positioning. Randomization was concealed and group assignment was not blinded. INTERVENTION Patients were randomized to either supine or prone positioning within 48 hours of meeting acute lung injury criteria, with those patients in the prone group being positioned within 4 hours of randomization and remaining prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days, after which they were positioned supine. Both groups were treated using lung protective ventilator and sedation protocols, extubation readiness testing, and hemodynamic, nutrition, and skin care guidelines. MAIN OUTCOME MEASURE Ventilator-free days to day 28. RESULTS The trial was stopped at the planned interim analysis on the basis of the prespecified futility stopping rule. There were no differences in the number of ventilator-free days between the 2 groups (mean [SD], 15.8 [8.5] supine vs 15.6 [8.6] prone; mean difference, −0.2 days; 95% CI, −3.6 to 3.2; P = .91). After controlling for age, Pediatric Risk of Mortality III score, direct vs indirect acute lung injury, and mode of mechanical ventilation at enrollment, the adjusted difference in ventilator-free days was 0.3 days (95% CI, −3.0 to 3.5; P = .87). There were no differences in the secondary end points, including proportion alive and ventilator-free on day 28 (P = .45), mortality from all causes (P&gt;.99), the time to recovery of lung injury (P = .78), organ-failure−free days (P = .88), and cognitive impairment (P = .16) or overall functional health (P = .12) at hospital discharge or on day 28. CONCLUSION Prone positioning does not significantly reduce ventilator-free days or improve other clinical outcomes in pediatric patients with acute lung injury.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>16014597</pmid><doi>10.1001/jama.294.2.229</doi><tpages>9</tpages></addata></record>
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source MEDLINE; American Medical Association Journals
subjects Adolescent
Biological and medical sciences
Child
Child, Preschool
Children & youth
Clinical outcomes
Effectiveness studies
Female
General aspects
Humans
Infant
Infant, Newborn
Inpatient care
Intensive Care Units, Pediatric
Male
Medical sciences
Pediatrics
Prone Position
Respiration, Artificial
Respiratory diseases
Respiratory Distress Syndrome, Adult - therapy
Respiratory Distress Syndrome, Newborn - therapy
Supine Position
title Effect of Prone Positioning on Clinical Outcomes in Children With Acute Lung Injury: A Randomized Controlled Trial
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