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临床试验/NCT03660033
NCT03660033Unknown不适用

ECG Monitoring During NRP: a False Sense of Security?

St. Justine's Hospital0 个研究点目标入组 60 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Time to pulse check

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

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

研究组 & 干预措施

With ECG

Experimental

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

干预措施: ECG in delivery room (Diagnostic Test)

Without ECG

No Intervention

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

结局指标

主要结局

Time to pulse check

时间窗: 1 minute

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

Time to start of chest compressions

时间窗: 2 minutes

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

Time to administration of epinephrine

时间窗: 3-4 minutes

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

次要结局

  • 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)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Andrew Assaad

Principal Investigator

St. Justine's Hospital

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