一种用于微创表面活性剂给药（LISA）的应用辅助设备的临床评估。
Clinical evaluation of an application aid for less-invasive surfactant administration (LISA).
机构信息
Department of Neonatology, University Children's Hospital Tubingen, Tubingen, Germany
Center for Pediatric Clinical Studies (CPCS), University Children's Hospital Tubingen, Tubingen, Germany.
出版信息
Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):211-214. doi: 10.1136/archdischild-2020-319792. Epub 2020 Oct 6.
BACKGROUND
Less-invasive surfactant administration (LISA) is increasingly used. We investigated the feasibility of a new LISA-device (Neofact®) in neonates.
DESIGN
Prospective observational pilot study with open-label LISA in two tertiary neonatal intensive care units.
PATIENTS
20 infants with a gestational age of ≥26+0/7 weeks and an indication for LISA (Respiratory Severity Score (RSS)≥5 or fraction of inspired oxygen (FiO) ≥0.30). Infants with respiratory tract malformations or unavailability of an instructed neonatologist were excluded.
MAIN OUTCOME MEASURES
Success of LISA, defined as laryngoscopy-confirmed intratracheal catheter position or a decrease in FiO by ≥0.05 or to 0.21, accompanied by an RSS decrease of ≥2; number of attempts needed for tracheal catheterisation.
RESULTS
20/57 screened infants were enrolled. Successful application occurred in 19/20 (95%). One application failed after three attempts. No device-related adverse events occurred. The median number of attempts was 2, success rate per attempt 19/31 (61%).
CONCLUSION
LISA via Neofact® appears feasible.
背景
微创表面活性剂给药（LISA）的应用越来越广泛。我们研究了一种新型 LISA 设备（Neofact®）在新生儿中的应用可行性。
设计
在两家三级新生儿重症监护病房进行的前瞻性观察性开放标签 LISA 初步研究。
患者
20 名胎龄≥26+0/7 周且有 LISA 适应证的婴儿（呼吸严重程度评分（RSS）≥5 或吸入氧分数（FiO）≥0.30）。排除有呼吸道畸形或无受过指导的新生儿科医生的婴儿。
主要观察指标
LISA 成功的定义为喉镜确认的气管内导管位置或 FiO 降低≥0.05 或降至 0.21，同时 RSS 降低≥2；气管导管插入所需的尝试次数。
结果
在筛选的 57 名婴儿中，有 20 名（95%）入组。经过三次尝试后，有一次应用失败。未发生与器械相关的不良事件。中位数尝试次数为 2 次，每次尝试的成功率为 19/31（61%）。
结论
通过 Neofact® 进行 LISA 似乎是可行的。
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