Department of Intensive Care, Fundación Valle del Lili, Cali, Colombia.
Translational Medicine Laboratory in Critical Care (TransLab-CCM), Universidad Icesi, Cali, Colombia.
JAMA. 2021 Dec 7;326(21):2161-2171. doi: 10.1001/jama.2021.20714.
The effect of high-flow oxygen therapy vs conventional oxygen therapy has not been established in the setting of severe COVID-19.
To determine the effect of high-flow oxygen therapy through a nasal cannula compared with conventional oxygen therapy on need for endotracheal intubation and clinical recovery in severe COVID-19.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, open-label clinical trial conducted in emergency and intensive care units in 3 hospitals in Colombia. A total of 220 adults with respiratory distress and a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen of less than 200 due to COVID-19 were randomized from August 2020 to January 2021, with last follow-up on February 10, 2021.
Patients were randomly assigned to receive high-flow oxygen through a nasal cannula (n = 109) or conventional oxygen therapy (n = 111).
The co-primary outcomes were need for intubation and time to clinical recovery until day 28 as assessed by a 7-category ordinal scale (range, 1-7, with higher scores indicating a worse condition). Effects of treatments were calculated with a Cox proportional hazards model adjusted for hypoxemia severity, age, and comorbidities.
Among 220 randomized patients, 199 were included in the analysis (median age, 60 years; n = 65 women [32.7%]). Intubation occurred in 34 (34.3%) randomized to high-flow oxygen therapy and in 51 (51.0%) randomized to conventional oxygen therapy (hazard ratio, 0.62; 95% CI, 0.39-0.96; P = .03). The median time to clinical recovery within 28 days was 11 (IQR, 9-14) days in patients randomized to high-flow oxygen therapy vs 14 (IQR, 11-19) days in those randomized to conventional oxygen therapy (hazard ratio, 1.39; 95% CI, 1.00-1.92; P = .047). Suspected bacterial pneumonia occurred in 13 patients (13.1%) randomized to high-flow oxygen and in 17 (17.0%) of those randomized to conventional oxygen therapy, while bacteremia was detected in 7 (7.1%) vs 11 (11.0%), respectively.
Among patients with severe COVID-19, use of high-flow oxygen through a nasal cannula significantly decreased need for mechanical ventilation support and time to clinical recovery compared with conventional low-flow oxygen therapy.
ClinicalTrials.gov Identifier: NCT04609462.
高流量氧疗与常规氧疗在严重 COVID-19 患者中的效果尚未确定。
确定经鼻高流量氧疗与常规氧疗相比，对严重 COVID-19 患者气管插管需求和临床康复的影响。
设计、地点和参与者：这是一项在哥伦比亚 3 家医院的急诊和重症监护病房进行的随机、开放标签临床试验。2020 年 8 月至 2021 年 1 月期间，共纳入 220 名因 COVID-19 出现呼吸窘迫和动脉血氧分压与吸入氧分数比值低于 200 的患者，将其随机分为经鼻高流量氧疗组（n=109）或常规氧疗组（n=111）。最后一次随访时间为 2021 年 2 月 10 日。
患者随机接受经鼻高流量氧疗（n=109）或常规氧疗（n=111）。
主要转归为气管插管需求和临床康复至第 28 天的时间，采用 7 级有序量表评估（范围为 1-7，得分越高表示病情越差）。采用 Cox 比例风险模型调整低氧血症严重程度、年龄和合并症对治疗效果进行计算。
在 220 名随机患者中，有 199 名患者纳入分析（中位年龄 60 岁；n=65 名女性[32.7%]）。经鼻高流量氧疗组有 34 名（34.3%）患者需要插管，常规氧疗组有 51 名（51.0%）患者需要插管（风险比，0.62；95%CI，0.39-0.96；P=0.03）。经鼻高流量氧疗组 28 天内临床康复的中位时间为 11（IQR，9-14）天，常规氧疗组为 14（IQR，11-19）天（风险比，1.39；95%CI，1.00-1.92；P=0.047）。经鼻高流量氧疗组有 13 名（13.1%）患者疑似发生细菌性肺炎，常规氧疗组有 17 名（17.0%）患者疑似发生细菌性肺炎；经鼻高流量氧疗组有 7 名（7.1%）患者发生菌血症，常规氧疗组有 11 名（11.0%）患者发生菌血症。
在严重 COVID-19 患者中，与常规低流量氧疗相比，经鼻高流量氧疗可显著降低机械通气支持需求和临床康复时间。
ClinicalTrials.gov 标识符：NCT04609462。
