ECG Monitoring During NRP: a False Sense of Security?

NCT03660033 | Unknown

• 1 other identifier: 2019-2022
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neonatal Resuscitation; Simulation

Keywords

Simulation; NRP; Resuscitation; ECG; Electrocardiogram

Outcome Measures

Primary Outcomes (3)

• Time to pulse check

  Time to pulse check once simulated manikin is programmed to be pulseless

  1 minute

• Time to start of chest compressions

  Time to start of chest compressions once simulated manikin is programmed to be pulseless

  2 minutes

• Time to administration of epinephrine

  Time to administration of epinephrine once simulated manikin is programmed to be pulseless

  3-4 minutes

Secondary Outcomes (5)

• Number of subsequent pulse checks

  1-10 minutes

• Method of pulse check

  0-10 minutes

• Time of electrode placement

  0-10 minutes

• Is the rhythm recognized?

  0-10 minutes

• Time to rhythm recognition

  0-10 minutes

Study Arms (2)

With ECG

EXPERIMENTAL

These teams will have access to ECG monitoring (intervention) during the scenario

Diagnostic Test: ECG in delivery room

Without ECG

NO INTERVENTION

These teams will NOT have access to ECG monitoring during the scenario

Interventions

ECG in delivery room DIAGNOSTIC_TEST

See arm/group discussions

With ECG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Any individual who does not regularly participate in neonatal resuscitation in the delivery room
• Any individual who refuses consent

Sponsors & Collaborators

• St. Justine's Hospital: lead

Related Publications (15)

• 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. 2017 Feb;37(2):172-176. doi: 10.1038/jp.2016.193. Epub 2016 Oct 27.

  PMID: 27787506 BACKGROUND

• 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.

  PMID: 21930554 BACKGROUND

• 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. No abstract available.

  PMID: 21297396 BACKGROUND

• 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. doi: 10.1038/sj.jp.7210740.

  PMID: 12082469 BACKGROUND

• Jaeggi E, Ohman A. Fetal and Neonatal Arrhythmias. Clin Perinatol. 2016 Mar;43(1):99-112. doi: 10.1016/j.clp.2015.11.007.

  PMID: 26876124 BACKGROUND

• 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.

  PMID: 18492509 BACKGROUND

• 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.

  PMID: 23090347 BACKGROUND

• 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.

  PMID: 28199732 BACKGROUND

• 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.

  PMID: 26477424 BACKGROUND

• 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.

  PMID: 20483522 BACKGROUND

• 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. doi: 10.1111/j.1440-1754.2007.01250.x. Epub 2007 Nov 12.

  PMID: 17999668 BACKGROUND

• 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. doi: 10.1177/000992288702600102.

  PMID: 3791833 BACKGROUND

• 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. doi: 10.1016/j.jpeds.2005.07.025.

  PMID: 16291367 BACKGROUND

• 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.

  PMID: 24534410 BACKGROUND

• Phillipos E, Solevag AL, Pichler G, Aziz K, van Os S, O'Reilly M, Cheung PY, Schmolzer GM. Heart Rate Assessment Immediately after Birth. Neonatology. 2016;109(2):130-8. doi: 10.1159/000441940. Epub 2015 Dec 19.

  PMID: 26684743 BACKGROUND

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Michael-Andrew Assaad, MD, MMEd (c)

CONTACT

514-771-9697; michael-andrew.assaad@mail.mcgill.ca

Ahmed Moussa, MD, MMed

CONTACT

514-345-4931; mjkmoussa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be invited to the mother-child simulation centre at CHU Sainte-Justine for a 60 minute simulation session during which they will complete two neonatal resuscitation scenarios (one of pulseless VT and the other of PEA). They will be randomized to either having access or not to ECG monitoring during the resuscitations.

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: September 6, 2018
• Study Start: October 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share