Department of Anesthesiology, Pain Medicine and Critical Care All India Institute of Medical Sciences, New Delhi, India.
Respir Care. 2021 Dec;66(12):1824-1830. doi: 10.4187/respcare.09130. Epub 2021 Sep 28.
Efficacy of high-flow nasal cannula (HFNC) over noninvasive ventilation (NIV) in severe coronavirus disease 2019 (COVID-19) pneumonia is not known. We aimed to assess the incidence of invasive mechanical ventilation in patients with acute hypoxemic respiratory failure due to COVID-19 treated with either HFNC or NIV.
This was a single-center randomized controlled trial performed in the COVID-19 ICU of a tertiary care teaching hospital in New Delhi, India. One hundred and nine subjects with severe COVID-19 pneumonia presenting with acute hypoxemic respiratory failure were recruited and allocated to either HFNC ( 55) or NIV ( 54) arm. Primary outcome was intubation by 48 h. Secondary outcomes were improvement in oxygenation by 48 h, intubation rate at day 7, and in-hospital mortality.
Baseline characteristics and [Formula: see text]/[Formula: see text] ratio were similar in both the groups. Intubation rate at 48 h was similar between the groups (33% NIV vs 20% HFNC, relative risk 0.6, 95% CI 0.31-1.15, = .12). Intubation rate at day 7 was lower in the HFNC (27.27%) compared to the NIV group (46.29%) (relative risk 0.59, 95% CI 0.35-0.99, = .045), and this difference remained significant after adjustment for the incidence of chronic kidney disease and the arterial pH (adjusted OR 0.40, 95% CI 0.17-0.93, = .03). Hospital mortality was similar between HFNC (29.1%) and NIV (46.2%) group (relative risk 0.6, 95% CI 0.38-1.04, = .06).
We were not able to demonstrate a statistically significant improvement of oxygenation parameters nor of the intubation rate at 48 h between NIV and HFNC. These findings should be further tested in a larger randomized controlled trial. The study was registered at the Clinical Trials Registry of India (www.ctri.nic.in; reference number: CTRI/2020/07/026835) on July 27, 2020.
高流量鼻导管(HFNC)与无创通气(NIV)在治疗严重 2019 冠状病毒病(COVID-19)肺炎中的疗效尚不清楚。我们旨在评估 HFNC 或 NIV 治疗因 COVID-19 导致急性低氧性呼吸衰竭的患者中,有创机械通气的发生率。
这是在印度新德里的一家三级教学医院的 COVID-19 ICU 进行的单中心随机对照试验。共招募了 109 例患有严重 COVID-19 肺炎并伴有急性低氧性呼吸衰竭的患者,并将其分配到 HFNC(55 例)或 NIV(54 例)组。主要结局为 48 小时内插管。次要结局为 48 小时内氧合改善、第 7 天插管率和住院死亡率。
两组的基线特征和[Formula: see text]/[Formula: see text] 比值相似。两组 48 小时内插管率相似(NIV 组为 33%,HFNC 组为 20%,相对风险 0.6,95%CI 0.31-1.15, =.12)。HFNC 组第 7 天的插管率(27.27%)低于 NIV 组(46.29%)(相对风险 0.59,95%CI 0.35-0.99, =.045),且在调整慢性肾脏病发生率和动脉 pH 值后,这一差异仍有统计学意义(调整后的 OR 0.40,95%CI 0.17-0.93, =.03)。HFNC 组(29.1%)和 NIV 组(46.2%)的住院死亡率相似(相对风险 0.6,95%CI 0.38-1.04, =.06)。
我们未能证明 NIV 和 HFNC 之间在 48 小时内的氧合参数改善或插管率有统计学意义的差异。这些发现应在更大规模的随机对照试验中进一步验证。该研究于 2020 年 7 月 27 日在印度临床试验注册处(www.ctri.nic.in;注册号:CTRI/2020/07/026835)注册。