Liu Xinyan, Wang Qizhi, Bi Yang, Yue Yanru, Song Xuan
ICU, Dong E Hospital, Liaocheng, Shandong Province, China.
ICU, Shandong Provincial Hospital affiliated to Shandong First Medical University, Jinan, Shandong Province, China.
PLoS One. 2025 Jan 14;20(1):e0316811. doi: 10.1371/journal.pone.0316811. eCollection 2025.
Patients with cerebral hemorrhage often require a tracheal intubation to protect the airway and maintain oxygenation. Due to the use of analgesic and sedative drugs during endotracheal intubation and the opening of the glottis may easily cause aspiration pneumonia. Ceftriaxone is a semi-synthetic third-generation cephalosporin with strong antimicrobial activity against most gram-positive and gram-negative bacteria. It can effectively prevent and treat aspiration pneumonia.
This is a prospective, randomized, controlled, double-blind clinical study. Patients with intracerebral hemorrhage (ICH) undergoing endotracheal intubation in Dong E Hospital of Shandong Province from April 2023 to April 2025 will be enrolled and randomly assigned to the intervention group or control group. The intervention group will be treated using 100mL 0.9% sodium chloride with 2g ceftriaxone intravenously over the course of one hour beginning within two hours after endotracheal intubation. The control group will be given 100mL 0.9% sodium chloride injection intravenously of the course of one hour beginning within two hours after endotracheal intubation. The primary outcome is the incidence of aspiration pneumonia within 48 hours after endotracheal intubation. Secondary outcomes include: intensity of antimicrobial use, length of hospital stay, duration without mechanical ventilation, and 28-day mortality.
The primary objective of this study is to explore whether a single dose of ceftriaxone administered during endotracheal intubation in patients with ICH reduced the incidence of pneumonia within 48 hours and provide evidence for the prevention of aspiration pneumonia in patients with ICH with endotracheal intubation.
The trial is registered at the Chinese Clinical Trial Registry: ChiCTR2200066837. Registered on December 19, 2022.
脑出血患者常需气管插管以保护气道并维持氧合。由于气管插管期间使用镇痛和镇静药物以及声门开放可能易导致吸入性肺炎。头孢曲松是一种半合成的第三代头孢菌素，对大多数革兰氏阳性和革兰氏阴性细菌具有强大的抗菌活性。它可有效预防和治疗吸入性肺炎。
这是一项前瞻性、随机、对照、双盲临床研究。2023年4月至2025年4月在山东省东阿医院接受气管插管的脑出血（ICH）患者将被纳入并随机分配至干预组或对照组。干预组将在气管插管后两小时内开始，在一小时内静脉输注含2g头孢曲松的100mL 0.9%氯化钠溶液。对照组将在气管插管后两小时内开始，在一小时内静脉输注100mL 0.9%氯化钠注射液。主要结局是气管插管后48小时内吸入性肺炎的发生率。次要结局包括：抗菌药物使用强度、住院时间、无机械通气持续时间和28天死亡率。
本研究的主要目的是探讨脑出血患者气管插管期间单次给予头孢曲松是否能降低48小时内肺炎的发生率，并为气管插管的脑出血患者预防吸入性肺炎提供证据。
该试验已在中国临床试验注册中心注册：ChiCTR2200066837。于2022年12月19日注册。
