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Clinical Trials/NCT03660033
NCT03660033UnknownNot Applicable

ECG Monitoring During NRP: a False Sense of Security?

St. Justine's Hospital0 sites60 target enrollmentStarted: October 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Primary Endpoint
Time to pulse check

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

With ECG

Experimental

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

Intervention: ECG in delivery room (Diagnostic Test)

Without ECG

No Intervention

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

Outcomes

Primary Outcomes

Time to pulse check

Time Frame: 1 minute

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

Time to start of chest compressions

Time Frame: 2 minutes

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

Time to administration of epinephrine

Time Frame: 3-4 minutes

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
St. Justine's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Andrew Assaad

Principal Investigator

St. Justine's Hospital

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