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

NCT01394783 | Completed Phase 4 DMC

• 1 other identifier: 3282-CER
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.
3. 3.Primary hypothesis:
4. 4.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

Keywords

Endotracheal intubation, Teaching, Videolaryngoscope

Outcome Measures

Primary Outcomes (1)

• Endotracheal intubation success rate.

  5 minutes

Secondary Outcomes (4)

• Time to intubation.

  5 minutes

• Rate of esophageal and right bronchial main stem intubations.

  15 minutes

• Supervisor's ease in recognizing problems with endotracheal intubation.

  15 minutes

• Resident's level of confidence in attempting endotracheal intubation.

  15 minutes

Study Arms (2)

Classic laryngoscope

OTHER

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

Device: Miller laryngoscope

Videolaryngoscope

OTHER

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.

Device: Storz videolaryngoscope

Interventions

Miller laryngoscope DEVICE

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

Classic laryngoscope

Storz videolaryngoscope DEVICE

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.

Videolaryngoscope

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Trainees: All residents registered in the three first years of the general pediatrics program of University of Montreal will be approached to participate in the study.
• Patients: All ETI attempted by pediatric residents in the NICU will be included in the study regardless of the patient weight or gestational age.

You may not qualify if:

• Trainees: Residents who perform less than five neonatal ETI per method.
• Patients: patients with major oral, cervical or upper airway malformations, urgent ETI with the inability to prepare in time the VL, and an unexpected difficult ETI.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine, Dept Neonatology

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

• Moussa A, Luangxay Y, Tremblay S, Lavoie J, Aube G, Savoie E, Lachance C. Videolaryngoscope for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20152156. doi: 10.1542/peds.2015-2156. Epub 2016 Feb 12.

  PMID: 26908701 DERIVED

Study Officials

• Ahmed Moussa, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ahmed Moussa

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: July 14, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

CA (1)