Richtrová Michaela, Košková Olga, Marcián Petr, Borák Libor, Bönischová Tereza, Fabián Dominik, Janků Martin, Joukal Marek, Vymazalová Kateřina, Štourač Petr
Department of Paediatric Anaesthesiology and Intensive Care Medicine, University Hospital Brno, Brno, Czech Republic.
Faculty of Medicine, Masaryk University, Brno, Czech Republic.
Ann Med. 2025 Dec;57(1):2561802. doi: 10.1080/07853890.2025.2561802. Epub 2025 Sep 22.
Orofacial 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.
A 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).
No tissue damage occurred in the CPPO group, while the control group had a 21.4% incidence of tissue injury ( = .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.
The 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.
口面部裂隙是常见的先天性畸形，会影响面部美观和功能。唇腭裂新生儿的插管操作具有挑战性，且口腔组织损伤风险高。本研究调查定制的腭部保护器（CPPO）在唇裂手术中改善插管安全性和减少组织损伤的应用情况。
进行了一项单中心随机新生儿亚研究，纳入55例行唇裂手术的新生儿。患者被随机分为干预组（使用CPPO）和对照组（标准插管，不使用CPPO）。主要目的是评估两组插管过程中口腔组织损伤的程度、严重程度及位置，次要目的包括插管时的喉镜图像（改良的Cormack-Lehane评分系统）、插管时间、尝试次数、插管尝试次数以及插管过程中的麻醉并发症。本研究已在www.clinicaltrials.gov注册（临床试验.gov标识符：NCT04422847和NCT04422964）。
CPPO组未发生组织损伤，而对照组组织损伤发生率为21.4%（P = 0.023）。次要结果显示，两组在插管时间或插管尝试次数上无统计学显著差异。与对照组（50%）相比，CPPO组困难插管的发生率较低（40.7%），但差异无统计学意义。
CPPO显著降低了唇裂手术新生儿插管过程中的组织损伤风险，且不增加插管时间或尝试次数。对于严重裂隙尤其有益，其应用可能有助于这些高危患者更安全的气道管理。
