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

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dc.contributor.authorMarcián, Petrcs
dc.contributor.authorBorák, Liborcs
dc.coverage.issue1cs
dc.coverage.volume57cs
dc.date.accessioned2025-10-14T13:07:35Z
dc.date.available2025-10-14T13:07:35Z
dc.date.issued2025-09-22cs
dc.description.abstractBackgroundOrofacial 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.en
dc.description.abstractBackgroundOrofacial 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.en
dc.formattextcs
dc.format.extent2561802-cs
dc.format.mimetypeapplication/pdfcs
dc.identifier.citationANNALS OF MEDICINE. 2025, vol. 57, issue 1, p. 2561802-.en
dc.identifier.doi10.1080/07853890.2025.2561802cs
dc.identifier.issn0785-3890cs
dc.identifier.orcid0000-0002-9458-9690cs
dc.identifier.orcid0000-0001-9785-0578cs
dc.identifier.other198893cs
dc.identifier.researcheridE-7359-2017cs
dc.identifier.researcheridCIK-1174-2022cs
dc.identifier.scopus55156647700cs
dc.identifier.scopus46661854700cs
dc.identifier.urihttps://hdl.handle.net/11012/255580
dc.language.isoencs
dc.relation.ispartofANNALS OF MEDICINEcs
dc.relation.urihttps://www.tandfonline.com/doi/full/10.1080/07853890.2025.2561802cs
dc.rightsCreative Commons Attribution 4.0 Internationalcs
dc.rights.accessopenAccesscs
dc.rights.sherpahttp://www.sherpa.ac.uk/romeo/issn/0785-3890/cs
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/cs
dc.subjectCleft lipen
dc.subjectnewbornsen
dc.subjectprotective obturatoren
dc.subject3D printingen
dc.subjectintubationen
dc.subjecttissue damageen
dc.subjectanesthesia managementen
dc.subjectpatient specific approachen
dc.subjectCleft lip
dc.subjectnewborns
dc.subjectprotective obturator
dc.subject3D printing
dc.subjectintubation
dc.subjecttissue damage
dc.subjectanesthesia management
dc.subjectpatient specific approach
dc.titleCustomized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trialen
dc.title.alternativeCustomized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trialen
dc.type.driverarticleen
dc.type.statusPeer-revieweden
dc.type.versionpublishedVersionen
eprints.grantNumberinfo:eu-repo/grantAgreement/MZ0/NU/NU23-06-00301cs
sync.item.dbidVAV-198893en
sync.item.dbtypeVAVen
sync.item.insts2025.10.14 15:07:35en
sync.item.modts2025.10.14 14:32:55en
thesis.grantorVysoké učení technické v Brně. Fakulta strojního inženýrství. Ústav mechaniky těles, mechatroniky a biomechanikycs
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