Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216305%3A26210%2F26%3A0198893" target="_blank" >RIV/00216305:26210/26:0198893 - isvavai.cz</a>

Alternative codes found

RIV/00216224:14110/25:00142208 RIV/65269705:_____/25:00082692

Result on the web

<a href="https://www.tandfonline.com/doi/full/10.1080/07853890.2025.2561802" target="_blank" >https://www.tandfonline.com/doi/full/10.1080/07853890.2025.2561802</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/07853890.2025.2561802" target="_blank" >10.1080/07853890.2025.2561802</a>

Result language

angličtina

Original language name

Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial

Original language description

BackgroundOrofacial clefts are common congenital malformations, affecting both facial aesthetics and function. Intubation in newborns with cleft lip and palate is challenging and carries a high risk of oral tissue damage. This study investigates the use of a customized protective palatal obturator (CPPO) to improve intubation safety and reduce tissue injury during cleft lip surgery.MethodsA single-center, randomized neonatal sub-study was conducted, including 55 newborns who underwent cleft lip surgery. Patients were randomized into an intervention group (CPPO use) and a control group (standard intubation without CPPO). The primary aim was to evaluate the degree of oral tissue injury during intubation, its severity, and location, in both groups, secondary aims included laryngoscopy image during intubation (modified Cormack-Lehane scoring system), intubation time, and attempts, number of intubations attempts and anesthesiologic complication during intubation. This study was registered on www.clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT04422847 and NCT04422964).ResultsNo tissue damage occurred in the CPPO group, while the control group had a 21.4% incidence of tissue injury (p = .023). Secondary outcomes showed no statistically significant differences between groups for intubation time or the number of intubation attempts. Difficult intubation was less frequent in the CPPO group (40.7%) compared to the control group (50%), though this difference was not statistically significant.ConclusionThe CPPO significantly reduces the risk of tissue damage during intubation in newborns undergoing cleft lip surgery, without increasing intubation time or attempts. It is particularly beneficial for severe clefts, and its use may facilitate safer airway management in these high-risk patients.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30218 - General and internal medicine

Project

Result was created during the realization of more than one project. More information in the Projects tab.

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

ANNALS OF MEDICINE

ISSN

0785-3890

e-ISSN

1365-2060

Volume of the periodical

57

Issue of the periodical within the volume

1

Country of publishing house

SE - SWEDEN

Number of pages

11

Pages from-to

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UT code for WoS article

001576417500001

EID of the result in the Scopus database

2-s2.0-105016768265