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

J 2025

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

RICHTROVÁ, Michaela; Olga KOŠKOVÁ; Petr MARCIAN; Libor BORAK; Tereza BÖNISCHOVÁ et al.

Základní údaje

Originální název

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

Autoři

RICHTROVÁ, Michaela; Olga KOŠKOVÁ; Petr MARCIAN; Libor BORAK; Tereza BÖNISCHOVÁ; Dominik FABIAN; Martin JANKŮ; Marek JOUKAL; Kateřina VYMAZALOVÁ a Petr ŠTOURAČ

Vydání

Annals of Medicine, ABINGDON, TAYLOR & FRANCIS LTD, 2025, 0785-3890

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30223 Anaesthesiology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 4.300 v roce 2024

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/25:00142226

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

Cleft lip; newborns; protective obturator; 3D printing; intubation; tissue damage; anesthesia management; patient specific approach

Štítky

14110229, 14110322, 14110514, 14110528, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 27. 1. 2026 14:57, Mgr. Eva Suchánková

Anotace

V originále

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.

Návaznosti

MUNI/A/1733/2024, interní kód MU

Název: Rozvoj vědeckých aspektů simulačního vzdělávání na LF MU II.

Investor: Masarykova univerzita, Rozvoj vědeckých aspektů simulačního vzdělávání na LF MU II.

MUNI/A/1771/2024, interní kód MU

Název: Optimalizace bezpečnosti intenzivní a perioperační péče III

Investor: Masarykova univerzita, Optimalizace bezpečnosti intenzivní a perioperační péče III

MUNI/A/1782/2024, interní kód MU

Název: Inovace v popáleninové medicíně a rekonstrukční plastické chirurgii II

Investor: Masarykova univerzita, Inovace v popáleninové medicíně a rekonstrukční plastické chirurgii II

NU23-06-00301, projekt VaV

Název: Využití moderních technologií v individualizovaném přístupu k operačnímu řešení rozštěpových vad obličeje u dětských pacientů

Investor: Ministerstvo zdravotnictví ČR, Využití moderních technologií v individualizovaném přístupu k operačnímu řešení rozštěpových vad obličeje u dětských pacientů

Citovat

RICHTROVÁ, Michaela; Olga KOŠKOVÁ; Petr MARCIAN; Libor BORAK; Tereza BÖNISCHOVÁ; Dominik FABIAN; Martin JANKŮ; Marek JOUKAL; Kateřina VYMAZALOVÁ a Petr ŠTOURAČ. Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial. Annals of Medicine. ABINGDON: TAYLOR & FRANCIS LTD, 2025, roč. 57, č. 1, s. 1-11. ISSN 0785-3890. Dostupné z: https://doi.org/10.1080/07853890.2025.2561802.

@article{2523877,
   author = {Richtrová, Michaela and Košková, Olga and Marcian, Petr and Borak, Libor and Bönischová, Tereza and Fabian, Dominik and Janků, Martin and Joukal, Marek and Vymazalová, Kateřina and Štourač, Petr},
   article_location = {ABINGDON},
   article_number = {1},
   doi = {https://doi.org/10.1080/07853890.2025.2561802},
   keywords = {Cleft lip; newborns; protective obturator; 3D printing; intubation; tissue damage; anesthesia management; patient specific approach},
   language = {eng},
   issn = {0785-3890},
   journal = {Annals of Medicine},
   title = {Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial},
   url = {https://www.tandfonline.com/doi/full/10.1080/07853890.2025.2561802},
   volume = {57},
   year = {2025}
}

TY  - JOUR
ID  - 2523877
AU  - Richtrová, Michaela - Košková, Olga - Marcian, Petr - Borak, Libor - Bönischová, Tereza - Fabian, Dominik - Janků, Martin - Joukal, Marek - Vymazalová, Kateřina - Štourač, Petr
PY  - 2025
TI  - Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial
JF  - Annals of Medicine
VL  - 57
IS  - 1
SP  - 1-11
EP  - 1-11
PB  - TAYLOR & FRANCIS LTD
SN  - 07853890
KW  - Cleft lip
KW  - newborns
KW  - protective obturator
KW  - 3D printing
KW  - intubation
KW  - tissue damage
KW  - anesthesia management
KW  - patient specific approach
UR  - https://www.tandfonline.com/doi/full/10.1080/07853890.2025.2561802
N2  - 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.
ER  -

RICHTROVÁ, Michaela; Olga KOŠKOVÁ; Petr MARCIAN; Libor BORAK; Tereza BÖNISCHOVÁ; Dominik FABIAN; Martin JANKŮ; Marek JOUKAL; Kateřina VYMAZALOVÁ a Petr ŠTOURAČ. Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial. \textit{Annals of Medicine}. ABINGDON: TAYLOR \&{} FRANCIS LTD, 2025, roč.~57, č.~1, s.~1-11. ISSN~0785-3890. Dostupné z: https://doi.org/10.1080/07853890.2025.2561802.

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