NCT06263790

Brief Summary

The study aims to compare the success and time of intubation through an 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

Same day

First QC Date

February 8, 2024

Last Update Submit

February 8, 2024

Conditions

Neonatal DiseaseIntubation; Difficult or Failed

Outcome Measures

Primary Outcomes (1)

  • Success at the first attempt

    The success of the first attempt will be defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer.

    3 minutes after the initiation of the procedure

Secondary Outcomes (2)

  • Time of device positioning

    3 minutes after the initiation of the procedure

  • Participant's opinion on difficulty of the procedure

    5 minutes after end of the procedure

Study Arms (2)

Intubation via laryngeal mask

EXPERIMENTAL

Participants will be required to position the endotracheal tube in the manikin via a laryngeal mask

Device: Intubating laryngeal mask

Intubation via direct laryngoscope

ACTIVE COMPARATOR

Participants will be required to position the endotracheal tube in the manikin via direct laryngoscopy

Device: Direct laryngoscopy

Interventions

Intubating laryngeal maskDEVICE

Intubation through a laryngeal mask

Intubation via laryngeal mask
Direct laryngoscopyDEVICE

Intubation by using a direct laryngoscope

Intubation via direct laryngoscope

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Level III NICU consultants and residents will be eligible to participate in the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 33773829BACKGROUND

  • 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.

    PMID: 15870667BACKGROUND

  • 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.

    PMID: 28409758BACKGROUND

  • 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.

    PMID: 20112078BACKGROUND

  • 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.

    PMID: 27470688BACKGROUND

  • 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.

    PMID: 40542416DERIVED

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Daniele Trevisanuto

CONTACT

3406632734daniele.trevisanuto@unipd.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share