Zhang Diwei, Gong Tianqing, Huang Qinghua, Zhang Qianqian, Liu Kai, Li Jia, Yu Hai, Cui Yu
Department of Anesthesiology, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
PLoS One. 2025 Jan 8;20(1):e0314782. doi: 10.1371/journal.pone.0314782. eCollection 2025.
Literature regarding the advantages of HFNC in infants for ensuring oxygen supply after non-cardiac surgery is insufficient. The purpose of our study is to compare COT vs. HFNC on postoperative outcomes in infants undergoing non-cardiac surgery. We hypothesize that prophylactic use of HFNC after non-cardiac surgery in infants would reduce the incidence of post-anesthesia hypoxemia and could also be adapted as first-line oxygen therapy after non-cardiac surgery.
This is a superior, single-blind, randomized controlled study. A total of 394 infants undergoing general anesthesia will be randomly assigned to accept COT or HFNC in a 1:1 ratio. The primary outcome is the rate of desaturation post-extubation. Secondary outcomes include the rate of mild upper airway obstruction, the rate of severe respiratory depression, the rate of transfer to PICU, duration of oxygen therapy, length of PACU stay, the time to reach full enteral feeding, and postoperative adverse events, including nasal injury, agitation, vomiting, and unplanned secondary surgery related to the initial surgery.
This is the first randomized controlled trial to explore the advantages of HFNC in infants to ensure oxygen supply after non-cardiac surgery. If favorable evidence is obtained, HFNC could be adopted as first-line oxygen therapy for infants following non-cardiac surgery.
The trial was registered at https://www.chictr.org.cn (Registration number: ChiCTR2400081600, Date: March 6, 2024).
关于高频鼻导管吸氧（HFNC）在非心脏手术后确保婴儿供氧方面优势的文献不足。我们研究的目的是比较持续气道正压通气（COT）与HFNC对接受非心脏手术婴儿术后结局的影响。我们假设在婴儿非心脏手术后预防性使用HFNC可降低麻醉后低氧血症的发生率，并且还可作为非心脏手术后的一线氧疗方法。
这是一项优效性、单盲、随机对照研究。总共394例接受全身麻醉的婴儿将按1:1的比例随机分配接受COT或HFNC。主要结局是拔管后血氧饱和度下降率。次要结局包括轻度上气道梗阻发生率、严重呼吸抑制发生率、转入儿科重症监护病房（PICU）的发生率、氧疗持续时间、麻醉后恢复室（PACU）停留时间、达到完全肠内喂养的时间以及术后不良事件，包括鼻损伤、烦躁、呕吐以及与初次手术相关的非计划二次手术。
这是第一项探索HFNC在非心脏手术后确保婴儿供氧优势的随机对照试验。如果获得有利证据，HFNC可作为非心脏手术后婴儿的一线氧疗方法。
该试验在https://www.chictr.org.cn注册（注册号：ChiCTR2400081600，日期：2024年3月6日）。
