ECG Monitoring During NRP: a False Sense of Security?

NCT ID: NCT03660033

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2019-05-31

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.

Conditions

Neonatal Resuscitation; Simulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

With ECG

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

Group Type: EXPERIMENTAL

ECG in delivery room

Intervention Type: DIAGNOSTIC_TEST

See arm/group discussions

Without ECG

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ECG in delivery room

See arm/group discussions

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael Andrew Assaad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Michael-Andrew Assaad, MD, MMEd (c)

Role: CONTACT

michael-andrew.assaad@mail.mcgill.ca

514-771-9697

Ahmed Moussa, MD, MMed

Role: CONTACT

mjkmoussa@gmail.com

514-345-4931 ext. 3109

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Other Identifiers

2019-2022

Identifier Type: -

Identifier Source: org_study_id