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Completed

NCT Number: NCT03046966

Manikin To Patient Intubation: Does It Translate?

This study evaluates a new approach to the instruction of pediatric residents in the skill of neonatal intubation. Half of the participants will receive focused simulation training and cognitive instruction while the other half will not. The collected data from both groups will be compared.

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Key information

Conditions

Intubation; Difficult or Failed

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

Current findings suggest that the training of pediatric residents is not sufficient prior to "live" tracheal intubations in the critical care setting. The current one to two days of airway management training as a part of resuscitation training (such as Pediatric Advanced Life Support (PALS) or Neonatal Resuscitation Program (NRP) is not sufficient to provide safe intubation skills.

This study will develop and implement tracheal intubation training using concepts of deliberate practice modeled after Ericsson. The concepts include focused training on a specific task, immediate feedback, time for problem solving and evaluation, and opportunities for repeated performance using a manikin. This proposal is an attempt to develop such a training model. Video recordings of live intubations will be reviewed and evaluated. The data between the two groups will be compared to see if there is improved intubation skills of live patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female residents from 18-89 years of age who have been assigned to the Neonatal Intensive Care Unit (NICU) for a monthly rotation are eligible to participate. At the beginning of all NICU rotations, all pediatric residents will be invited to participate in this research.

Exclusion criteria

  • Any pediatric resident who does not wish to participate

Treatment and study plan

Intervention: Receives Training

Procedure
  • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:
  • Using state of the art technology, a Storz C-MAC video laryngoscope
  • Identifying anatomical landmarks
  • Practice on the manikin until intubation occurs within 15 seconds

Intervention: Control No Training

Other
  • Does not receive simulation training with PI. Only standard training.

Primary outcomes

  1. Successful Intubation Encounters on Live Neonates

    Time frame: 1 month- neonatal intensive care unit (NICU) rotation

    Residents reported the number of successful intubation encounters they performed during their one month long NICU rotation. A successful intubation encounter is an intubation procedure where the resident successfully placed the the endotracheal tube (ETT) through the vocal cords into the trachea. Placement was confirmed with xray, chest auscultation, improvement in heart rate, and CO2 detectors.

Secondary outcomes

  1. Successful Intubations on the First Attempt

    Time frame: 1 month- NICU rotation

    Each resident reported the number of successful intubation encounters requiring one attempt on live infants during their NICU rotation. An intubation attempt occurs any time the laryngoscope enters the neonate's mouth. There can be multiple intubation attempts in one intubation encounter. However this outcome focuses on intubation encounters where the neonate was intubated on the first attempt by the resident.

  2. Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation

    Time frame: 1 month- NICU rotation

    The mean number of intubation encounters performed by each resident during their NICU rotation was compared between the Control and Intervention groups.

  3. Change in Time to Intubate the Mannequin

    Time frame: 1 month- NICU rotation

    All study residents intubated the mannequin before and after their NICU rotation. The total time of the mannequin intubation encounter was recorded. The difference in the time from end of the NICU rotation and the baseline time (beginning of the NICU rotation) was calculated.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2017
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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