Georg M Schmölzer, Gerhard Pichler, Anne Lee Solevåg, Brenda Hiu Yan Law, Souvik Mitra, Michael Wagner, Daniel Pfurtscheller, Maryna Yaskina, Po-Yin Cheung
{"title":"在对窒息新生儿进行心肺复苏时，持续充气和胸外按压与 3:1 的胸外按压和通气比（SURV1VE）：分组随机对照试验。","authors":"Georg M Schmölzer, Gerhard Pichler, Anne Lee Solevåg, Brenda Hiu Yan Law, Souvik Mitra, Michael Wagner, Daniel Pfurtscheller, Maryna Yaskina, Po-Yin Cheung","doi":"10.1136/archdischild-2023-326383","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>In newborn infants requiring chest compression (CC) in the delivery room (DR) does continuous CC superimposed by a sustained inflation (CC+SI) compared with a 3:1 compression:ventilation (3:1 C:V) ratio decreases time to return of spontaneous circulation (ROSC).</p><p><strong>Design: </strong>International, multicenter, prospective, cluster cross-over randomised trial.</p><p><strong>Setting: </strong>DR in four hospitals in Canada and Austria, PARTICIPANTS: Newborn infants >28 weeks' gestation who required CC.</p><p><strong>Interventions: </strong>Hospitals were randomised to CC+SI or 3:1 C:V then crossed over to the other intervention.</p><p><strong>Main outcome measure: </strong>The primary outcome was time to ROSC, defined as the duration of CC until an increase in heart rate >60/min determined by auscultation of the heart, which was maintained for 60 s. Sample size of 218 infants (109/group) was sufficient to detect a clinically important 33% reduction (282 vs 420 s of CC) in time to ROSC. Analysis was intention-to-treat.</p><p><strong>Results: </strong>Patient recruitment occurred between 19 October 2017 and 22 September 2022 and randomised 27 infants (CC+SI (n=12), 3:1 C:V (n=15), two (one per group) declined consent). All 11 infants in the CC+SI group and 12/14 infants in the 3:1 C:V group achieved ROSC in the DR. The median (IQR) time to ROSC was 90 (60-270) s and 615 (174-780) s (p=0.0502 (log rank), p=0.16 (cox proportional hazards regression)) with CC+SI and 3:1 C:V, respectively. Mortality was 2/11 (18.2%) with CC+SI versus 8/14 (57.1%) with 3:1 C:V (p=0.10 (Fisher's exact test), OR (95% CI) 0.17; (0.03 to 1.07)). The trial was stopped due to issues with ethics approval and securing trial insurance as well as funding reasons.</p><p><strong>Conclusion: </strong>The time to ROSC and mortality was not statistical different between CC+SI and 3:1 C:V.</p><p><strong>Trial registration: </strong>NCT02858583.</p>","PeriodicalId":8177,"journal":{"name":"Archives of Disease in Childhood - Fetal and Neonatal Edition","volume":" ","pages":"428-435"},"PeriodicalIF":3.9000,"publicationDate":"2024-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11228189/pdf/","citationCount":"0","resultStr":"{\"title\":\"<u>Su</u>stained inflation and chest comp<u>r</u>ession <u>v</u>ersus 3:<u>1</u> chest compression to <u>v</u>entilation ratio during cardiopulmonary resuscitation of asphyxiated n<u>e</u>wborns (SURV1VE): A cluster randomised controlled trial.\",\"authors\":\"Georg M Schmölzer, Gerhard Pichler, Anne Lee Solevåg, Brenda Hiu Yan Law, Souvik Mitra, Michael Wagner, Daniel Pfurtscheller, Maryna Yaskina, Po-Yin Cheung\",\"doi\":\"10.1136/archdischild-2023-326383\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>In newborn infants requiring chest compression (CC) in the delivery room (DR) does continuous CC superimposed by a sustained inflation (CC+SI) compared with a 3:1 compression:ventilation (3:1 C:V) ratio decreases time to return of spontaneous circulation (ROSC).</p><p><strong>Design: </strong>International, multicenter, prospective, cluster cross-over randomised trial.</p><p><strong>Setting: </strong>DR in four hospitals in Canada and Austria, PARTICIPANTS: Newborn infants >28 weeks' gestation who required CC.</p><p><strong>Interventions: </strong>Hospitals were randomised to CC+SI or 3:1 C:V then crossed over to the other intervention.</p><p><strong>Main outcome measure: </strong>The primary outcome was time to ROSC, defined as the duration of CC until an increase in heart rate >60/min determined by auscultation of the heart, which was maintained for 60 s. Sample size of 218 infants (109/group) was sufficient to detect a clinically important 33% reduction (282 vs 420 s of CC) in time to ROSC. Analysis was intention-to-treat.</p><p><strong>Results: </strong>Patient recruitment occurred between 19 October 2017 and 22 September 2022 and randomised 27 infants (CC+SI (n=12), 3:1 C:V (n=15), two (one per group) declined consent). All 11 infants in the CC+SI group and 12/14 infants in the 3:1 C:V group achieved ROSC in the DR. The median (IQR) time to ROSC was 90 (60-270) s and 615 (174-780) s (p=0.0502 (log rank), p=0.16 (cox proportional hazards regression)) with CC+SI and 3:1 C:V, respectively. Mortality was 2/11 (18.2%) with CC+SI versus 8/14 (57.1%) with 3:1 C:V (p=0.10 (Fisher's exact test), OR (95% CI) 0.17; (0.03 to 1.07)). The trial was stopped due to issues with ethics approval and securing trial insurance as well as funding reasons.</p><p><strong>Conclusion: </strong>The time to ROSC and mortality was not statistical different between CC+SI and 3:1 C:V.</p><p><strong>Trial registration: </strong>NCT02858583.</p>\",\"PeriodicalId\":8177,\"journal\":{\"name\":\"Archives of Disease in Childhood - Fetal and Neonatal Edition\",\"volume\":\" \",\"pages\":\"428-435\"},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2024-06-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11228189/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Archives of Disease in Childhood - Fetal and Neonatal Edition\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1136/archdischild-2023-326383\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PEDIATRICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Archives of Disease in Childhood - Fetal and Neonatal Edition","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/archdischild-2023-326383","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PEDIATRICS","Score":null,"Total":0}
Sustained inflation and chest compression versus 3:1 chest compression to ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns (SURV1VE): A cluster randomised controlled trial.
Objective: In newborn infants requiring chest compression (CC) in the delivery room (DR) does continuous CC superimposed by a sustained inflation (CC+SI) compared with a 3:1 compression:ventilation (3:1 C:V) ratio decreases time to return of spontaneous circulation (ROSC).
Setting: DR in four hospitals in Canada and Austria, PARTICIPANTS: Newborn infants >28 weeks' gestation who required CC.
Interventions: Hospitals were randomised to CC+SI or 3:1 C:V then crossed over to the other intervention.
Main outcome measure: The primary outcome was time to ROSC, defined as the duration of CC until an increase in heart rate >60/min determined by auscultation of the heart, which was maintained for 60 s. Sample size of 218 infants (109/group) was sufficient to detect a clinically important 33% reduction (282 vs 420 s of CC) in time to ROSC. Analysis was intention-to-treat.
Results: Patient recruitment occurred between 19 October 2017 and 22 September 2022 and randomised 27 infants (CC+SI (n=12), 3:1 C:V (n=15), two (one per group) declined consent). All 11 infants in the CC+SI group and 12/14 infants in the 3:1 C:V group achieved ROSC in the DR. The median (IQR) time to ROSC was 90 (60-270) s and 615 (174-780) s (p=0.0502 (log rank), p=0.16 (cox proportional hazards regression)) with CC+SI and 3:1 C:V, respectively. Mortality was 2/11 (18.2%) with CC+SI versus 8/14 (57.1%) with 3:1 C:V (p=0.10 (Fisher's exact test), OR (95% CI) 0.17; (0.03 to 1.07)). The trial was stopped due to issues with ethics approval and securing trial insurance as well as funding reasons.
Conclusion: The time to ROSC and mortality was not statistical different between CC+SI and 3:1 C:V.
期刊介绍：
Archives of Disease in Childhood is an international peer review journal that aims to keep paediatricians and others up to date with advances in the diagnosis and treatment of childhood diseases as well as advocacy issues such as child protection. It focuses on all aspects of child health and disease from the perinatal period (in the Fetal and Neonatal edition) through to adolescence. ADC includes original research reports, commentaries, reviews of clinical and policy issues, and evidence reports. Areas covered include: community child health, public health, epidemiology, acute paediatrics, advocacy, and ethics.
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