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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by St. Justine's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01394783
First received: May 31, 2011
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.

Condition Intervention Phase
Intubation, Intratracheal
Device: Miller laryngoscope
Device: Storz videolaryngoscope
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Videolaryngoscope vs Classic Laryngoscope in Teaching Neonatal Endotracheal Intubation: a Randomized Controlled Trial.

Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Endotracheal intubation success rate. [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to intubation. [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Defined as the time from insertion of the laryngoscope blade in the patients' mouth until it is pulled out.

  • Rate of esophageal and right bronchial main stem intubations. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Esophageal intubation is diagnosed when there is absence of clinical signs of a successful endotracheal intubation and possibly air entry in the stomach by auscultation. Right bronchial main stem intubation is diagnosed on chest x-ray.

  • Supervisor's ease in recognizing problems with endotracheal intubation. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Short survey after each intubation.

  • Resident's level of confidence in attempting endotracheal intubation. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Short survey after each intubation.


Estimated Enrollment: 400
Study Start Date: July 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Classic laryngoscope
Phase 1 and 2: Endotracheal intubation using the classic laryngoscope with Miller blade 0 or 1 according to weight of infant.
Device: Miller laryngoscope
Phase 1 and 2: Endotracheal intubation using the Miller laryngoscope with blade 0 or 1 according to weight of infant.
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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394783

Contacts
Contact: Ahmed Moussa, MD 514-345-4931 ext 3109 ahmed-moussa@hotmail.com

Locations
Canada, Quebec
CHU Sainte-Justine, Dept Neonatology Recruiting
Montréal, Quebec, Canada, H3T 1C5
Contact: Ahmed Moussa, MD    514-345-4931 ext 3109    ahmed-moussa@hotmail.com   
Principal Investigator: Ahmed Moussa, MD         
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Ahmed Moussa, MD St. Justine's Hospital
  More Information

No publications provided

Responsible Party: Dr Ahmed Moussa, MD, FAAP, FRCPC, Centre Hospitalier Universitaire Sainte-Justine
ClinicalTrials.gov Identifier: NCT01394783     History of Changes
Other Study ID Numbers: 3282-CER
Study First Received: May 31, 2011
Last Updated: July 19, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Justine's Hospital:
Endotracheal intubation, Teaching, Videolaryngoscope

ClinicalTrials.gov processed this record on September 18, 2014