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Resident Training Enhanced by New Innovations: Teleintubation

Primary Purpose

Asphyxia Neonatorum

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education for intubation skills
No added education for intubation skills
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asphyxia Neonatorum

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Pediatric residents

Exclusion criteria:

  • Residents from other departments
  • Neonatology fellows
  • Medical students
  • Medical school Faculty

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Education for intubation skills

    No added education for intubation skills

    Arm Description

    Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.

    Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.

    Outcomes

    Primary Outcome Measures

    Skill in Intubating Neonatal Manikin
    Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab

    Secondary Outcome Measures

    Knowledge Concerning Intubation of Neonates
    Score on cognitive test on intubation of neonates.Scores ranged on scale from 0 to 21 , with higher score indicating greater knowledge (better outcome).

    Full Information

    First Posted
    October 6, 2015
    Last Updated
    March 31, 2023
    Sponsor
    University of Arkansas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02572427
    Brief Title
    Resident Training Enhanced by New Innovations: Teleintubation
    Official Title
    Video Laryngoscopy for Enhancing and Maintaining Intubation Skills
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Arkansas

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The overall goal of this study was to create a simulation environment with repeated practice for residents and intense, immediate feedback. Repeated simulations for neonatal resuscitation when coupled with clinical experience have been shown to improve resident confidence.The investigators sought to determine if resident exposure to individual training and video laryngoscopy using the C-MAC video laryngoscope would improve cognitive skills and decrease intubation times in a neonatal manikin. The primary outcome was time to intubation after one year. The secondary outcome was the ability to retain cognitive instruction related to intubation
    Detailed Description
    Objective: Tracheal intubation of infants and children is a critical lifesaving skill, but many upper level pediatric residents are unable to successfully intubate neonates or pediatric patients in a timely manner. Simulation has been shown to be effective in teaching procedural skills, but it is not known if improvements in intubation skills can persist. The investigators sought to determine if video laryngoscopy could be used to enhance resident intubation skills that would be retained for one year. Methods: There were 67 Pediatric and Internal Medicine/Pediatric residents, levels 1-4, who completed the study and were randomized by month of service into non-intervention (NI, n= 36) and intervention (IN, n=31) groups. IN residents observed the intubation portion of the Neonatal Resuscitation Program (NRP) training video and received cognitive instruction and 30 minutes of hands on instruction using a video laryngoscope. At the study's conclusion, 12 months after enrollment, residents completed a survey of intubations of live patients over the past year, a cognitive assessment of intubation, and were timed on intubating a manikin. Results were analyzed by Student's T-Test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asphyxia Neonatorum

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Education for intubation skills
    Arm Type
    Experimental
    Arm Description
    Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.
    Arm Title
    No added education for intubation skills
    Arm Type
    Active Comparator
    Arm Description
    Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.
    Intervention Type
    Other
    Intervention Name(s)
    Education for intubation skills
    Intervention Description
    Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab.
    Intervention Type
    Other
    Intervention Name(s)
    No added education for intubation skills
    Intervention Description
    Routine training in neonatal resuscitation but no added experience in simulation lab.
    Primary Outcome Measure Information:
    Title
    Skill in Intubating Neonatal Manikin
    Description
    Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab
    Time Frame
    Up to two minutes
    Secondary Outcome Measure Information:
    Title
    Knowledge Concerning Intubation of Neonates
    Description
    Score on cognitive test on intubation of neonates.Scores ranged on scale from 0 to 21 , with higher score indicating greater knowledge (better outcome).
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: Pediatric residents Exclusion criteria: Residents from other departments Neonatology fellows Medical students Medical school Faculty
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard W Hall, M.D.
    Organizational Affiliation
    University of Arkansas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Resident Training Enhanced by New Innovations: Teleintubation

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