Sponsor study identifier
interventional
268
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2013
Actual (reported)Study Completion
June 2014
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 31, 2011
Actual (reported)July 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 14, 2011
Actual (reported)June 2013
Actual (reported)June 2014
Actual (reported)Endotracheal intubation success rate.
5 minutes
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
Phase 1 and 2: Endotracheal intubation using the classic laryngoscope with Miller blade 0 or 1 according to weight of infant.
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.
Phase 1 and 2: Endotracheal intubation using the Miller laryngoscope with blade 0 or 1 according to weight of infant.
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.
CHU Sainte-Justine, Dept Neonatology
Montreal, Quebec, H3T 1C5, Canada
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.
Ahmed Moussa, MD
St. Justine's Hospital
268 participants (actual enrollment reported by the registry).
First Submitted
May 31, 2011
First Posted
July 14, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
June 2013
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
November 19, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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