Simulation Clinical Trial
Official title:
ECG Monitoring During NRP: a False Sense of Security?
ECG monitoring is relatively new mode of monitoring in the delivery room. While its use has been positively received by many practitioners of NRP, concerns have been raised about delaying chest compressions for a pulseless baby who may have electrical cardiac activity. It is unknown whether ECG leads do indeed provide a false sense of security in the delivery room. The investigators will be investigating this further using simulation.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | May 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Regular providers of neonatal resuscitation at our institution - This includes residents, fellows, neonatal nurse practitioners, attending physicians, transport nurses and respiratory therapists - Consents to the study (through a process of recruitment and informed consent) Exclusion Criteria: - Any individual who does not regularly participate in neonatal resuscitation in the delivery room - Any individual who refuses consent |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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St. Justine's Hospital |
Ali N, Sawyer T, Barry J, Grover T, Ades A. Resuscitation practices for infants in the NICU, PICU and CICU: results of a national survey. J Perinatol. 2016 Oct 27. doi: 10.1038/jp.2016.193. [Epub ahead of print] — View Citation
Fouzas S, Priftis KN, Anthracopoulos MB. Pulse oximetry in pediatric practice. Pediatrics. 2011 Oct;128(4):740-52. doi: 10.1542/peds.2011-0271. Epub 2011 Sep 19. Review. — View Citation
Hannibal GB. It started with Einthoven: the history of the ECG and cardiac monitoring. AACN Adv Crit Care. 2011 Jan-Mar;22(1):93-6. doi: 10.1097/10.1097/NCI.0b013e3181fffe4c. — View Citation
Hay WW Jr, Rodden DJ, Collins SM, Melara DL, Hale KA, Fashaw LM. Reliability of conventional and new pulse oximetry in neonatal patients. J Perinatol. 2002 Jul-Aug;22(5):360-6. — View Citation
Jaeggi E, Öhman A. Fetal and Neonatal Arrhythmias. Clin Perinatol. 2016 Mar;43(1):99-112. doi: 10.1016/j.clp.2015.11.007. Review. — View Citation
Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6. — View Citation
Katheria A, Rich W, Finer N. Electrocardiogram provides a continuous heart rate faster than oximetry during neonatal resuscitation. Pediatrics. 2012 Nov;130(5):e1177-81. doi: 10.1542/peds.2012-0784. Epub 2012 Oct 22. — View Citation
Kevat AC, Bullen DV, Davis PG, Kamlin CO. A systematic review of novel technology for monitoring infant and newborn heart rate. Acta Paediatr. 2017 May;106(5):710-720. doi: 10.1111/apa.13786. Epub 2017 Mar 6. Review. — View Citation
Louis D, Sundaram V, Kumar P. Pulse oximeter sensor application during neonatal resuscitation: a randomized controlled trial. Pediatrics. 2014 Mar;133(3):476-82. doi: 10.1542/peds.2013-2175. Epub 2014 Feb 17. — View Citation
Maxwell LG, Harris AP, Sendak MJ, Donham RT. Monitoring the resuscitation of preterm infants in the delivery room using pulse oximetry. Clin Pediatr (Phila). 1987 Jan;26(1):18-20. — View Citation
O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Feasibility of and delay in obtaining pulse oximetry during neonatal resuscitation. J Pediatr. 2005 Nov;147(5):698-9. — View Citation
Phillipos E, Solevåg AL, Pichler G, Aziz K, van Os S, O'Reilly M, Cheung PY, Schmölzer GM. Heart Rate Assessment Immediately after Birth. Neonatology. 2016;109(2):130-8. doi: 10.1159/000441940. Epub 2015 Dec 19. Review. — View Citation
Singh JK, Kamlin CO, Morley CJ, O'Donnell CP, Donath SM, Davis PG. Accuracy of pulse oximetry in assessing heart rate of infants in the neonatal intensive care unit. J Paediatr Child Health. 2008 May;44(5):273-5. Epub 2007 Nov 12. — View Citation
Voogdt KG, Morrison AC, Wood FE, van Elburg RM, Wyllie JP. A randomised, simulated study assessing auscultation of heart rate at birth. Resuscitation. 2010 Aug;81(8):1000-3. doi: 10.1016/j.resuscitation.2010.03.021. Epub 2010 May 18. — View Citation
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. Review. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to pulse check | Time to pulse check once simulated manikin is programmed to be pulseless | 1 minute | |
Primary | Time to start of chest compressions | Time to start of chest compressions once simulated manikin is programmed to be pulseless | 2 minutes | |
Primary | Time to administration of epinephrine | Time to administration of epinephrine once simulated manikin is programmed to be pulseless | 3-4 minutes | |
Secondary | Number of subsequent pulse checks | After initial pulse check | 1-10 minutes | |
Secondary | Method of pulse check | Directly visualize (using video review) if participants use auscultation or palpation to check the pulse | 0-10 minutes | |
Secondary | Time of electrode placement | FOR ECG GROUP ONLY: time to application of ECG electrodes | 0-10 minutes | |
Secondary | Is the rhythm recognized? | FOR ECG GROUP ONLY: is the rhythm recognized Y/N? | 0-10 minutes | |
Secondary | Time to rhythm recognition | FOR ECG GROUP ONLY: measure at what time the team finally recognizes the baby's cardiac rhythm | 0-10 minutes |
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