Trial reportItalian journal of pediatrics2025
Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial.
Trial report in Italian journal of pediatrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06263790 (Intubating Laryngeal Mask vs Direct Laryngoscopy), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial
Who cites it
0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe aimed to compare endotracheal intubation through a laryngeal mask vs. using a direct laryngoscope in a manikin simulating a term infant.
methodsA randomized, controlled, crossover (AB/BA) trial of intubation through a laryngeal mask vs. a direct laryngoscope in a manikin simulating a term infant. Thirty-four tertiary neonatal intensive care unit consultants and pediatric residents who had previous experience with intubating laryngeal airway and direct laryngoscopy participated. The primary outcome measure was the success of the procedure at the first attempt. The secondary outcome measures included the total time of endotracheal tube positioning and participant's opinion on insertion difficulty and overall difficulty.
resultsSuccess at first attempt was 34/34 with the laryngeal mask (100%) and 26/34 with the direct laryngoscope (76%) (difference in percentage 24%, 95% confidence interval 5-41%; p = 0.008). Median time of endotracheal tube positioning was 24 s (IQR 19-30) with both devices (p = 0.86). Insertion difficulty (p = 0.96) and overall difficulty (p = 0.99) were not statistically different between the devices.
conclusionsIn a term infant manikin model, positioning the endotracheal tube through the laryngeal mask increased the success at the first attempt compared to direct laryngoscopy, without extending the duration of the procedure or affecting the perceived difficulty. REGISTRATION: clinicaltrial.gov NCT06263790. Registered 16 February 2024, https://clinicaltrials.gov/study/NCT06263790 .
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