Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial
NCT ID: NCT06263790
Last Updated: 2024-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2024-03-31
2024-03-31
Brief Summary
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This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.
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Detailed Description
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Objectives: To compare success and time of intubation through intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
Methods: This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure was the intubation success rate at the first attempt. Secondary outcome measures were the total time needed for the endotracheal tube positioning (calculated as the sum of the time of device positioning in all attempts), and the participant's opinion on using the device (evaluated using a Likert scale).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Intubation via laryngeal mask
Participants will be required to position the endotracheal tube in the manikin via a laryngeal mask
Intubating laryngeal mask
Intubation through a laryngeal mask
Intubation via direct laryngoscope
Participants will be required to position the endotracheal tube in the manikin via direct laryngoscopy
Direct laryngoscopy
Intubation by using a direct laryngoscope
Interventions
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Intubating laryngeal mask
Intubation through a laryngeal mask
Direct laryngoscopy
Intubation by using a direct laryngoscope
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
65 Years
ALL
Yes
Sponsors
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University Hospital Padova
OTHER
Responsible Party
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Daniele Trevisanuto
Associate Professor
Central Contacts
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References
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Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr. 2005 May;146(5):638-41. doi: 10.1016/j.jpeds.2005.01.029.
Sawyer T, Foglia E, Hatch LD, Moussa A, Ades A, Johnston L, Nishisaki A. Improving neonatal intubation safety: A journey of a thousand miles. J Neonatal Perinatal Med. 2017;10(2):125-131. doi: 10.3233/NPM-171686.
Gerstein NS, Braude DA, Hung O, Sanders JC, Murphy MF. The Fastrach Intubating Laryngeal Mask Airway: an overview and update. Can J Anaesth. 2010 Jun;57(6):588-601. doi: 10.1007/s12630-010-9272-x. Epub 2010 Jan 29.
Sauer CW, Kong JY, Vaucher YE, Finer N, Proudfoot JA, Boutin MA, Leone TA. Intubation Attempts Increase the Risk for Severe Intraventricular Hemorrhage in Preterm Infants-A Retrospective Cohort Study. J Pediatr. 2016 Oct;177:108-113. doi: 10.1016/j.jpeds.2016.06.051. Epub 2016 Jul 26.
Monfredini C, Cavallin F, Ouedraogo P, Ezzahraoui L, Pasta E, Trevisanuto D, Villani PE. Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial. Ital J Pediatr. 2025 Jun 20;51(1):196. doi: 10.1186/s13052-025-01988-8.
Other Identifiers
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NEOUNIPD1(2024)
Identifier Type: -
Identifier Source: org_study_id
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