Videolaryngoscope vs Classic Laryngoscope in Teaching Neonatal Endotracheal Intubation: a Randomized Controlled Trial.

Summary

Every year thousands of neonates born in North America need extensive resuscitation which often includes endotracheal intubation (ETI). In these situations, Pediatricians assume the role of Neonatal Resuscitation Program (NRP) providers and are responsible of the ETI procedure. They acquire this skill during residency training in the Neonatal Intensive Care Unit (NICU) and the delivery room. Difficulties in performing neonatal ETI lie in the small size of the mouth and airway of the neonate, and their particular anatomy of the larynx. This limited visibility represents a challenge even for the experienced clinician. Recently, a new videolaryngoscope (VL) technique has been introduced to the adult and pediatric medical fields as described respectively by Kaplan et al. and Weiss et al. In 2009, Vanderhal et al. reported a preliminary experience in the newborn population. Video assisted intubation could be a method of choice in teaching neonatal ETI.

To the best of our knowledge, there is no human study comparing the VL to the classic laryngoscope (CL) for acquiring the skill of neonatal ETI in the NICU.

This study aims:

1. To assess if the videolaryngoscope is superior to the classic laryngoscope in acquiring the neonatal endotracheal intubation skill in the Neonatal Intensive Care Unit; and
2. To assess if once the skill is acquired with the videolaryngoscope this experience is transferable to the use of the classic laryngoscope by showing a persistent difference in success rate in favor of the videolaryngoscope group.

The hypothesis are

1. Primary hypothesis:

In the Neonatal Intensive Care Unit, use of the videolaryngoscope will increase success rate of endotracheal intubation by 20% compared to the classic laryngoscope. Later, acquired experience from the videolaryngoscope will be transferable to the use of the classic laryngoscope by showing a persistent difference in success rate of 20% in favor of the videolaryngoscope group.
2. Secondary hypothesis We expect that the videolaryngoscope will decrease time to intubation, and decrease rate of esophageal and right bronchial main stem intubations. It will also improve teaching of endotracheal intubations to pediatric residents by helping supervisors recognize problems related to intubation and by improving residents' level of confidence in performing the skill.

Conditions

• Intubation, Intratracheal

Interventions

DEVICE

Miller laryngoscope

Phase 1 and 2: Endotracheal intubation using the Miller laryngoscope with blade 0 or 1 according to weight of infant.

DEVICE

Storz videolaryngoscope

Phase 1: Endotracheal intubation using the videolaryngoscope with blade 0 or 1 according to weight of infant. Videolaryngoscope will be used to proceed to endotracheal intubation indirectly with the use of the video monitor for guidance. Phase 2: Endotracheal intubation using the classic laryngoscope with Miller blade 0 or 1 according to weight of infant.

Sponsors & Collaborators

• St. Justine's Hospital

  lead OTHER

Principal Investigators

• Ahmed Moussa, MD · St. Justine's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

CROSSOVER

Eligibility

Max Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2013-06-30

Completion

2014-06-30

Countries

• Canada

Study Locations