高流量鼻导管吸氧用于婴幼儿肺炎所致急性低氧性呼吸衰竭的早期呼吸管理：CENTURI随机临床试验
High-flow nasal oxygen in infants and children for early respiratory management of pneumonia-induced acute hypoxemic respiratory failure: the CENTURI randomized clinical trial.
作者信息
Kandasamy Sasidaran, Rameshkumar Ramachandran, Sangaralingam Thangavelu, Krishnamoorthy Nedunchelian, Shankar N C Gowri, Vijayakumar Vimalraj, Sridharan Balaji
机构信息
Advanced Pediatric Critical Care Centre, Pediatric Acute Care Education & Research (PACER) Unit, Department of Pediatrics, Mehta Multi Speciality Hospitals, Chennai, Tamil Nadu 600 031 India.
Division of Pediatric Critical Care, Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006 India.
出版信息
Intensive Care Med Paediatr Neonatal. 2024;2(1):15. doi: 10.1007/s44253-024-00031-8. Epub 2024 Apr 1.
OBJECTIVE
To compare the effectiveness of early high-flow nasal cannula (HFNC) and low-flow oxygen support (LFOS) in children under 5 years with acute hypoxemic respiratory failure (AHRF) due to severe community-acquired pneumonia in low-middle-income countries.
METHODS
An open-label randomized clinical trial enrolled children aged 2-59 months with AHRF due to severe community-acquired pneumonia and randomized into HFNC and LFOS. In the LFOS group, the patient received cold wall oxygen humidified by bubbling through sterile water administered through simple nasal prongs at a fixed flow rate of 2 L/min. In the HFNC group, the patient received humidified, heated (37 °C), high-flow oxygen at a flow rate assigned based on weight range, with a titratable oxygen fraction. The primary outcome was treatment failure in 72 h (escalating the respiratory support method using any modality other than primary intervention).
RESULTS
Data was analyzed intention-to-treat (HFNC = 124; LFOS = 120). Median (IQR) age was 12 (6-20) and 11 (6-27) months, respectively. Treatment failure occurred in a significantly lower proportion in the HFNC group (7.3%, = 9/124) as compared to the LFOS group (20%, = 24/120) (relative risk = 0.36, 95% CI 0.18 to 0.75; = 0.004; adjusted hazard ratio 0.34, 95% CI 0.16 to 0.73; = 0.006). The intubation rate was significantly lower in the HFNC group (7.3%, = 9/124 vs. 16.7%, = 20/120; relative risk = 0.44, 95% CI 0.21 to 0.92, = 0.023). There were no significant differences noted in other secondary outcomes. No mortality occurred.
CONCLUSION
High-flow nasal cannula oxygen therapy used as early respiratory support in children under 5 years with acute hypoxemic respiratory failure due to severe community-acquired pneumonia was associated with significantly lower treatment failure compared with standard low-flow oxygen support.
TRIAL REGISTRATION
CTRI/2016/04/006788. Registered 01 April 2016, https://ctri.nic.in/Clinicaltrials/advsearch.php.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s44253-024-00031-8.
目的
比较早期高流量鼻导管吸氧（HFNC）与低流量氧疗（LFOS）对中低收入国家5岁以下因重症社区获得性肺炎导致急性低氧性呼吸衰竭（AHRF）儿童的疗效。
方法
一项开放标签随机临床试验纳入了2至59个月因重症社区获得性肺炎导致AHRF的儿童，并随机分为HFNC组和LFOS组。在LFOS组，患者通过简单鼻导管以2L/min的固定流速接受经无菌水鼓泡加湿的冷壁氧疗。在HFNC组，患者接受根据体重范围分配流速、可调节氧浓度的加温（37°C）、加湿的高流量氧疗。主要结局为72小时内治疗失败（使用除主要干预措施以外的任何方式升级呼吸支持方法）。
结果
采用意向性分析（HFNC组 = 124例；LFOS组 = 120例）。两组儿童的年龄中位数（四分位间距）分别为12（6 - 20）个月和11（6 - 27）个月。与LFOS组（20%，24/120）相比，HFNC组治疗失败的比例显著更低（7.3%，9/124）（相对风险 = 0.36，95%置信区间0.18至0.75；P = 0.004；调整后风险比0.34，95%置信区间0.16至0.73；P = 0.006）。HFNC组的插管率显著更低（7.3%，9/124 vs. 16.7%，20/120；相对风险 = 0.44，95%置信区间0.21至0.92，P = 0.023）。其他次要结局未见显著差异。无死亡病例。
结论
对于5岁以下因重症社区获得性肺炎导致急性低氧性呼吸衰竭的儿童，早期采用高流量鼻导管吸氧疗法作为呼吸支持，与标准低流量氧疗相比，治疗失败率显著降低。
试验注册
CTRI/2016/04/006788。于2016年4月1日注册，https://ctri.nic.in/Clinicaltrials/advsearch.php。
补充信息
在线版本包含可在10.1007/s44253-024-00031-8获取的补充材料。
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