Bradycardia Clinical Trial
— SURV1VEOfficial title:
SURV1VE-Trial - Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns: A Randomized Controlled Trial
NCT number | NCT02858583 |
Other study ID # | 1.0 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 19, 2017 |
Est. completion date | September 22, 2022 |
Verified date | September 2022 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation? Overall objective: CC superimposed by sustained inflation will improve short- and long-term outcomes in preterm (>28 weeks or older) and term newborns. Hypothesis to be tested Primary hypothesis: By using CC superimposed by sustained inflation (CC+SI) during CPR the time needed to achieve return of spontaneous circulation (ROSC) compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated newborns.
Status | Completed |
Enrollment | 25 |
Est. completion date | September 22, 2022 |
Est. primary completion date | September 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Minutes to 20 Minutes |
Eligibility | Inclusion Criteria: - Infants (term or preterm infants >28 weeks' gestation) requiring CC in the delivery room will be eligible for the trial. Exclusion Criteria: - Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation (e.g. congenital diaphragmatic hernia), or congenital heart disease requiring intervention in the neonatal period. Infants would be also excluded if their parents refused to give consent to this study. |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Graz | Graz | |
Austria | Medical University Vienna | Vienna | |
Canada | Royal Alexandra Hospital | Edmonton | |
Canada | IWK Health Centre | Halifax |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Austria, Canada,
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Li ES, Cheung PY, Lee TF, Lu M, O'Reilly M, Schmolzer GM. Return of spontaneous Circulation Is Not Affected by Different Chest Compression Rates Superimposed with Sustained Inflations during Cardiopulmonary Resuscitation in Newborn Piglets. PLoS One. 2016 Jun 15;11(6):e0157249. doi: 10.1371/journal.pone.0157249. eCollection 2016. — View Citation
Li ES, Cheung PY, O'Reilly M, Schmolzer GM. Change in tidal volume during cardiopulmonary resuscitation in newborn piglets. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F530-3. doi: 10.1136/archdischild-2015-308363. Epub 2015 Jul 1. — View Citation
Li ES, Cheung PY, Pichler G, Aziz K, Schmolzer GM. Respiratory function and near infrared spectroscopy recording during cardiopulmonary resuscitation in an extremely preterm newborn. Neonatology. 2014;105(3):200-4. doi: 10.1159/000357609. Epub 2014 Jan 24. — View Citation
Li ES, Gorens I, Cheung PY, Lee TF, Lu M, O'Reilly M, Schmolzer GM. Chest Compressions during Sustained Inflations Improve Recovery When Compared to a 3:1 Compression:Ventilation Ratio during Cardiopulmonary Resuscitation in a Neonatal Porcine Model of Asphyxia. Neonatology. 2017;112(4):337-346. doi: 10.1159/000477998. Epub 2017 Aug 3. — View Citation
Perlman JM, Wyllie J, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S204-41. doi: 10.1161/CIR.0000000000000276. No abstract available. — View Citation
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Schmolzer GM, O Reilly M, Fray C, van Os S, Cheung PY. Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F455-F460. doi: 10.1136/archdischild-2017-313037. Epub 2017 Oct 7. — View Citation
Schmolzer GM, O'Reilly M, Labossiere J, Lee TF, Cowan S, Nicoll J, Bigam DL, Cheung PY. 3:1 compression to ventilation ratio versus continuous chest compression with asynchronous ventilation in a porcine model of neonatal resuscitation. Resuscitation. 2014 Feb;85(2):270-5. doi: 10.1016/j.resuscitation.2013.10.011. Epub 2013 Oct 22. — View Citation
Schmolzer GM, O'Reilly M, Labossiere J, Lee TF, Cowan S, Qin S, Bigam DL, Cheung PY. Cardiopulmonary resuscitation with chest compressions during sustained inflations: a new technique of neonatal resuscitation that improves recovery and survival in a neonatal porcine model. Circulation. 2013 Dec 3;128(23):2495-503. doi: 10.1161/CIRCULATIONAHA.113.002289. Epub 2013 Oct 2. — View Citation
Sobotka KS, Hooper SB, Crossley KJ, Ong T, Schmolzer GM, Barton SK, McDougall AR, Miller SL, Tolcos M, Klingenberg C, Polglase GR. Single Sustained Inflation followed by Ventilation Leads to Rapid Cardiorespiratory Recovery but Causes Cerebral Vascular Leakage in Asphyxiated Near-Term Lambs. PLoS One. 2016 Jan 14;11(1):e0146574. doi: 10.1371/journal.pone.0146574. eCollection 2016. Erratum In: PLoS One. 2016;11(5):e0156193. — View Citation
Sobotka KS, Polglase GR, Schmolzer GM, Davis PG, Klingenberg C, Hooper SB. Effects of chest compressions on cardiovascular and cerebral hemodynamics in asphyxiated near-term lambs. Pediatr Res. 2015 Oct;78(4):395-400. doi: 10.1038/pr.2015.117. Epub 2015 Jun 18. — View Citation
Solevag AL, Cheung PY, Lie H, O'Reilly M, Aziz K, Nakstad B, Schmolzer GM. Chest compressions in newborn animal models: A review. Resuscitation. 2015 Nov;96:151-5. doi: 10.1016/j.resuscitation.2015.08.001. Epub 2015 Aug 19. — View Citation
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Solevag AL, Dannevig I, Wyckoff M, Saugstad OD, Nakstad B. Extended series of cardiac compressions during CPR in a swine model of perinatal asphyxia. Resuscitation. 2010 Nov;81(11):1571-6. doi: 10.1016/j.resuscitation.2010.06.007. Epub 2010 Jul 17. — View Citation
Solevag AL, Dannevig I, Wyckoff M, Saugstad OD, Nakstad B. Return of spontaneous circulation with a compression:ventilation ratio of 15:2 versus 3:1 in newborn pigs with cardiac arrest due to asphyxia. Arch Dis Child Fetal Neonatal Ed. 2011 Nov;96(6):F417-21. doi: 10.1136/adc.2010.200386. Epub 2011 Mar 10. — View Citation
Solevag AL, Lee TF, Lu M, Schmolzer GM, Cheung PY. Tidal volume delivery during continuous chest compressions and sustained inflation. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F85-F87. doi: 10.1136/archdischild-2016-311043. Epub 2016 Aug 26. — View Citation
Solevag AL, Madland JM, Gjaerum E, Nakstad B. Minute ventilation at different compression to ventilation ratios, different ventilation rates, and continuous chest compressions with asynchronous ventilation in a newborn manikin. Scand J Trauma Resusc Emerg Med. 2012 Oct 17;20:73. doi: 10.1186/1757-7241-20-73. — View Citation
Solevag AL, Schmolzer GM. Optimal Chest Compression Rate and Compression to Ventilation Ratio in Delivery Room Resuscitation: Evidence from Newborn Piglets and Neonatal Manikins. Front Pediatr. 2017 Jan 23;5:3. doi: 10.3389/fped.2017.00003. eCollection 2017. — View Citation
Srikantan SK, Berg RA, Cox T, Tice L, Nadkarni VM. Effect of one-rescuer compression/ventilation ratios on cardiopulmonary resuscitation in infant, pediatric, and adult manikins. Pediatr Crit Care Med. 2005 May;6(3):293-7. doi: 10.1097/01.PCC.0000161621.74554.15. — View Citation
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Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e169-201. doi: 10.1016/j.resuscitation.2015.07.045. Epub 2015 Oct 15. No abstract available. — View Citation
* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Return of spontaneous Circulation | Duration of chest compression heart rate is >60/min for 60sec. | up to 60 Minutes of chest compression | |
Secondary | Mortality | Number of infants who die until discharge - comparison between group | Until infant is discharge from hospital (maximum of 30 weeks after birth) | |
Secondary | Number of Epinephrine dosses during resuscitation | How many doses of epinephrine are given - comparison between group | During resuscitation (up to 60 minutes) | |
Secondary | Rate of brain injury | Brain injury either by ultrasound or magnet resonance imaging - comparison between group | Until infant is discharge from hospital (maximum of 30 weeks after birth) | |
Secondary | Necrotizing enterocolitis | Number of infants who develop Necrotizing enterocolitis - comparison between group | Until infant is discharge from hospital (maximum of 30 weeks after birth) |
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