Table_1_Nasotracheal vs. Orotracheal Intubation and Post-extubation Airway Obstruction in Critically Ill Children: An Open-Label Randomized Controlled Trial.docx

Background: The data on long-term nasotracheal intubation among mechanically ventilated critically ill children is limited. The purpose of this study was to compare the rate of post-extubation airway obstruction (PEAO) with nasotracheal and orotracheal intubation.
Methods: This open-label randomized controlled trial was conducted in PICU of a tertiary care and teaching hospital in North India from January-December 2020 involving intubated children aged 3 months−12 years. After written informed consent, children were randomized into nasotracheal and orotracheal intubation groups. Post-extubation, modified Westley's croup score (mWCS) was used at 10-timepoints (0-min, 30 min, 1, 2, 3, 6, 12, 24, 36, and 48-h after extubation) to monitor for PEAO. The primary outcome was the rate of PEAO; and secondary outcomes were time taken for intubation, number of intubation attempts, complications during intubation, unplanned extubation, repeated intubations, tube malposition/displacement, endotracheal tube blockade, ventilator associated pneumonia, skin trauma, extubation failure/re-intubation, duration of PICU stay, and mortality.
Results: Seventy children were randomized into nasotracheal (n = 30) and orotracheal (n = 40) groups. Both the groups were similar in baseline characteristics. The rate of PEAO was similar between nasotracheal and orotracheal groups (10 vs. 20%, p = 0.14). The maximum mWCS and mWCS at 10-timepoints were similar in two groups. The time taken for intubation was significantly longer (85 vs. 48 s, p < 0.001) in nasotracheal group, whereas other secondary outcomes were similar in two groups.
Conclusion: The rate of PEAO was not different between nasotracheal and orotracheal groups.
Clinical Trial Registration:http://ctri.nic.in, Identifier: CTRI/2020/01/022988.

背景：目前关于机械通气重症儿童长期经鼻气管插管的相关研究数据较为匮乏。本研究旨在对比经鼻气管插管与经口气管插管患者的拔管后气道梗阻（post-extubation airway obstruction, PEAO）发生率。
方法：本研究为开放标签随机对照试验，于2020年1月至12月在印度北部一所三级教学医院的儿科重症监护病房（Pediatric Intensive Care Unit, PICU）开展，纳入年龄为3个月~12岁的气管插管儿童。在获取书面知情同意后，将患儿随机分为经鼻气管插管组与经口气管插管组。拔管后，于10个时间点（拔管后0分钟、30分钟、1小时、2小时、3小时、6小时、12小时、24小时、36小时及48小时）采用改良威斯利哮吼评分（modified Westley's croup score, mWCS）监测PEAO发生情况。本研究的主要结局为PEAO发生率；次要结局包括气管插管操作时长、插管尝试次数、插管期间并发症、非计划性拔管、再次插管、气管导管位置异常/移位、气管导管堵塞、呼吸机相关性肺炎、皮肤损伤、拔管失败/再插管、儿科重症监护病房停留时长及病死率。
结果：本研究共纳入70例患儿，随机分为经鼻气管插管组（n=30）与经口气管插管组（n=40）。两组患儿基线特征无统计学差异。经鼻与经口气管插管组的PEAO发生率无显著差异（10% vs. 20%，p=0.14）。两组患儿的最高改良威斯利哮吼评分及各时间点的改良威斯利哮吼评分均无显著差异。经鼻气管插管组的气管插管操作时长显著长于经口气管插管组（85s vs. 48s，p<0.001），其余次要结局指标组间均无统计学差异。
结论：经鼻气管插管与经口气管插管组的拔管后气道梗阻发生率无显著差异。
临床试验注册：http://ctri.nic.in，注册编号：CTRI/2020/01/022988。