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ECG Monitoring During NRP: a False Sense of Security?

ECG Monitoring During NRP: a False Sense of Security?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03660033
Enrollment
60
Registered
2018-09-06
Start date
2018-10-31
Completion date
2019-05-31
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Resuscitation, Simulation

Keywords

Simulation, NRP, Resuscitation, ECG, Electrocardiogram

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.

Detailed description

The aim of this study is to evaluate whether the presence of ECG monitoring has an impact on the resuscitative steps of NRP providers. Participants will be invited to the mother-child simulation center 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. Investigators will plan to have participant teams perform the second scenario two weeks after the first scenario. This will be to hopefully mitigate repetition bias, as both scenarios will involve a pulseless newborn. 1. Resuscitation team and equipment Participants will be invited to be part of a three-person resuscitation team (physician or nurse practitioner, respiratory therapist and nurse) to complete the scenarios. A high-fidelity manikin will be utilized in all scenarios (Laerdal © Sim NewB). All necessary equipment as per NRP guidelines for neonatal resuscitation will be present at the bedside for the team to use. 2. Simulation scenarios In each group, the participants will be asked to proceed with the resuscitation of a newborn in the delivery room. Two different rhythms were chosen to see if changes seen with one abnormal appearing rhythm (ventricular tachycardia) can be replicated with a second normal appearing rhythm (PEA). Both of these rhythms cannot be considered normal as the newborn is pulseless. For the VT scenario, the newborn will be born in pulseless VT, with a pulse reading of 120 on the ECG monitor. There will have been an uneventful delivery. Participants will be expected to perform defibrillation, endotracheal intubation, chest compressions, umbilical venous catheter placement and intravenous epinephrine. Once the epinephrine is administered, the manikin will have a palpable pulse of 100, which will end the scenario. For the PEA scenario, the newborn will have a history of volume loss secondary to placenta previa. Because of the prolonged in utero asphyxia, the baby will be born in PEA arrest, with a heart rate display on the monitor of 80-90. In this scenario, resuscitative steps will include positive pressure ventilation, endotracheal intubation, chest compressions, umbilical venous catheter placement and intravenous epinephrine. Once the epinephrine is administered, the manikin will have a palpable pulse of 100, which will end the scenario. 3. Video recording of scenarios In order to be precise about time measurements, the investigators will record the resuscitations with the help of a video camera. The camera shot will only include the newborn manikin and the resuscitation team's hands. These recordings will not provide any identification data and will be for the sole purpose collecting data for this study. The video will be analyzed by the principal investigator and deleted in accordance with IRB guidelines. The following data below will be collected. Please note that all time measurements will be from the start of the scenario. * Time to pulse checks * Time to application of ECG electrodes (for relevant scenarios) * Number of subsequent pulse checks after application of ECG electrodes * Method of pulse check (auscultation, palpation of the umbilical cord or brachial pulse) * Time to start of chest compressions * Time to administration of epinephrine A questionnaire for each participant will collect the following data prior to the simulations: occupation, number of years of training in neonatology, number of years of experience in neonatology, last NRP course and approximate number of resuscitations in past year.

Interventions

DIAGNOSTIC_TESTECG in delivery room

See arm/group discussions

Sponsors

St. Justine's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to pulse check1 minuteTime to pulse check once simulated manikin is programmed to be pulseless
Time to start of chest compressions2 minutesTime to start of chest compressions once simulated manikin is programmed to be pulseless
Time to administration of epinephrine3-4 minutesTime to administration of epinephrine once simulated manikin is programmed to be pulseless

Secondary

MeasureTime frameDescription
Is the rhythm recognized?0-10 minutesFOR ECG GROUP ONLY: is the rhythm recognized Y/N?
Number of subsequent pulse checks1-10 minutesAfter initial pulse check
Time to rhythm recognition0-10 minutesFOR ECG GROUP ONLY: measure at what time the team finally recognizes the baby's cardiac rhythm
Method of pulse check0-10 minutesDirectly visualize (using video review) if participants use auscultation or palpation to check the pulse
Time of electrode placement0-10 minutesFOR ECG GROUP ONLY: time to application of ECG electrodes

Contacts

Primary ContactMichael-Andrew Assaad, MD, MMEd (c)
michael-andrew.assaad@mail.mcgill.ca514-771-9697
Backup ContactAhmed Moussa, MD, MMed
mjkmoussa@gmail.com514-345-4931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026