ECG Monitoring During NRP: a False Sense of Security?

September 4, 2018 updated by: Michael Andrew Assaad, St. Justine's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With ECG
These teams will have access to ECG monitoring (intervention) during the scenario
Diagnostic test: ECG in delivery room
See arm/group discussions
No Intervention: Without ECG
These teams will NOT have access to ECG monitoring during the scenario

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to pulse check
Time Frame: 1 minute
Time to pulse check once simulated manikin is programmed to be pulseless
1 minute
Time to start of chest compressions
Time Frame: 2 minutes
Time to start of chest compressions once simulated manikin is programmed to be pulseless
2 minutes
Time to administration of epinephrine
Time Frame: 3-4 minutes
Time to administration of epinephrine once simulated manikin is programmed to be pulseless
3-4 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subsequent pulse checks
Time Frame: 1-10 minutes
After initial pulse check
1-10 minutes
Method of pulse check
Time Frame: 0-10 minutes
Directly visualize (using video review) if participants use auscultation or palpation to check the pulse
0-10 minutes
Time of electrode placement
Time Frame: 0-10 minutes
FOR ECG GROUP ONLY: time to application of ECG electrodes
0-10 minutes
Is the rhythm recognized?
Time Frame: 0-10 minutes
FOR ECG GROUP ONLY: is the rhythm recognized Y/N?
0-10 minutes
Time to rhythm recognition
Time Frame: 0-10 minutes
FOR ECG GROUP ONLY: measure at what time the team finally recognizes the baby's cardiac rhythm
0-10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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