Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Paracelsus Medical University, Müllner-Haupt-Str. 48, 5020, Salzburg, Austria.
Clinical Research Center Salzburg, Salzburg, Austria.
BMC Pediatr. 2022 Nov 4;22(1):637. doi: 10.1186/s12887-022-03714-3.
In respiratory distress syndrome, many neonatology centers worldwide perform minimal invasive surfactant application in premature infants, using small-diameter catheters for endotracheal intubation and surfactant administration.
In this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomized to two different modes of endotracheal catheterization: Flexible charrière-4 feeding tube inserted using Magill forceps (group 1) and semi-rigid catheter (group 2). Primary outcome was duration of laryngoscopy. Secondary outcomes were complication rate (intraventricular hemorrhage, soft-tissue damage in first week of life) and vital parameters during laryngoscopy. Between 2019 and 2020, 31 infants were included in the study. Prior to in-vivo testing, laryngoscopy durations were studied on a neonatal airway mannequin in students, nurses and doctors.
Mean gestational age and birth weight were 27 + 6/7 weeks and 1009 g; and 28 + 0/7 weeks and 1127 g for group 1 and 2, respectively. Length of laryngoscopy was similar in both groups (61.1 s and 64.9 s) overall (p.77) and adjusted for weight (p.70) or gestational age (p.95). Laryngoscopy failed seven times in group 1 (43.8%) and four times (26.7%) in group 2 (p.46). Longer laryngoscopy was associated with lower oxygen saturation with lowest levels occurring after failed laryngoscopy attempts. Secondary outcomes were similar in both groups. In vitro data on 40 students, 40 nurses and 12 neonatologists showed significant faster laryngoscopy in students and nurses group 2 (p < .0001) unlike in neonatologists (p.13).
This study showed no difference in laryngoscopy duration in endotracheal catheterization when comparing semi-rigid and flexible catheters for minimal invasive surfactant application in preterm infants. In accordance with preliminary data and in contrast to published in-vitro trials, experienced neonatologists were able to perform endotracheal catheterization using both semi-rigid and flexible catheters at similar rates and ease, in vitro and in vivo.
ClinicalTrials.gov. NCT05024435 Registered 27 August 2021-Retrospectively registered.
在呼吸窘迫综合征中，全球许多新生儿科中心都采用小直径导管对早产儿进行微创表面活性剂应用，以进行气管内插管和表面活性剂给药。
在这项单中心、开放标签、随机对照试验中，使用标准化微创方案后需要进行表面活性剂给药的早产儿，随机分为两种不同的气管内导管插入方式：使用 Magill 夹插入的柔性 Charrière-4 喂养管（第 1 组）和半刚性导管（第 2 组）。主要结局是喉镜检查的持续时间。次要结局是并发症发生率（脑室内出血、生命第一周的软组织损伤）和喉镜检查期间的生命体征。2019 年至 2020 年期间，共有 31 名婴儿纳入研究。在体内测试之前，在学生、护士和医生的新生儿气道模型上研究了喉镜检查持续时间。
第 1 组和第 2 组的平均胎龄和出生体重分别为 27+6/7 周和 1009g；28+0/7 周和 1127g。两组的喉镜检查时间总体上相似（61.1s 和 64.9s；p=0.77），且经体重调整（p=0.70）或胎龄调整（p=0.95）后也相似。第 1 组有 7 次喉镜检查失败（43.8%），第 2 组有 4 次（26.7%）（p=0.46）。较长的喉镜检查时间与较低的氧饱和度相关，最低水平出现在喉镜检查失败后。两组的次要结局相似。在对 40 名学生、40 名护士和 12 名新生儿科医生的体外数据显示，学生和护士组 2 的喉镜检查速度明显快于第 1 组（p<0.0001），而与新生儿科医生不同（p=0.13）。
本研究比较了微创表面活性剂应用中半刚性和柔性导管在早产儿中的气管内插管，结果显示在喉镜检查持续时间方面无差异。与初步数据一致，并与已发表的体外试验相反，经验丰富的新生儿科医生能够以相似的速度和易用性，在体外和体内使用半刚性和柔性导管进行气管内插管。
ClinicalTrials.gov。NCT05024435 于 2021 年 8 月 27 日注册-回顾性注册。
