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Trial record 3 of 3 for:    18492509 [PUBMED-IDS]

ECG Monitoring During NRP: a False Sense of Security?

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ClinicalTrials.gov Identifier: NCT03660033
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Andrew Assaad, St. Justine's Hospital

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.

Condition or disease Intervention/treatment Phase
Neonatal Resuscitation Simulation Diagnostic Test: ECG in delivery room Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ECG Monitoring During NRP: a False Sense of Security?
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2019

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



Primary Outcome Measures :
  1. Time to pulse check [ Time Frame: 1 minute ]
    Time to pulse check once simulated manikin is programmed to be pulseless

  2. Time to start of chest compressions [ Time Frame: 2 minutes ]
    Time to start of chest compressions once simulated manikin is programmed to be pulseless

  3. Time to administration of epinephrine [ Time Frame: 3-4 minutes ]
    Time to administration of epinephrine once simulated manikin is programmed to be pulseless


Secondary Outcome Measures :
  1. Number of subsequent pulse checks [ Time Frame: 1-10 minutes ]
    After initial pulse check

  2. Method of pulse check [ Time Frame: 0-10 minutes ]
    Directly visualize (using video review) if participants use auscultation or palpation to check the pulse

  3. Time of electrode placement [ Time Frame: 0-10 minutes ]
    FOR ECG GROUP ONLY: time to application of ECG electrodes

  4. Is the rhythm recognized? [ Time Frame: 0-10 minutes ]
    FOR ECG GROUP ONLY: is the rhythm recognized Y/N?

  5. 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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660033


Contacts
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Contact: Michael-Andrew Assaad, MD, MMEd (c) 514-771-9697 michael-andrew.assaad@mail.mcgill.ca
Contact: Ahmed Moussa, MD, MMed 514-345-4931 ext 3109 mjkmoussa@gmail.com

Sponsors and Collaborators
St. Justine's Hospital

Publications:

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Responsible Party: Michael Andrew Assaad, Principal Investigator, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03660033     History of Changes
Other Study ID Numbers: 2019-2022
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Andrew Assaad, St. Justine's Hospital:
Simulation
NRP
Resuscitation
ECG
Electrocardiogram