头盔无创通气已用于COVID-19患者,前提是头盔接口比面罩接口更有效地进行高气道正压长时间治疗,但是关于其有效性的数据是有限的。
评估头盔式无创通气与常规呼吸支持相比是否能降低COVID-19肺炎所致急性低氧性呼吸衰竭患者的死亡率。
这是一个多中心,务实,2021年2月8日至2021年11月16日在沙特阿拉伯和科威特的8个地点进行的随机临床试验。包括因怀疑或确认COVID-19而导致急性低氧性呼吸衰竭的成年患者(n=320)。主要结果的最终随访日期为2021年12月14日。
患者随机接受头盔式无创通气(n=159)或常规呼吸支持(n=161),其中包括面罩无创通气,高流量鼻腔吸氧,和标准氧气。
主要结局是28天全因死亡率。有12个预设的次要结果,包括气管插管,气压伤,皮肤压力损伤,和严重不良事件。
在322名随机分组的患者中,320人被包括在主要分析中,所有的人都完成了审判。中位年龄是58岁,男性187人(58.4%)。28天内,头盔无创通气组159例患者中有43例(27.0%)死亡,而常规呼吸支持组161例患者中有42例(26.1%)死亡(风险差异,1.0%[95%CI,-8.7%至10.6%];相对风险,1.04[95%CI,0.72-1.49];P=.85)。28天内,头盔无创通气组159例患者中的75例(47.2%)需要气管插管,而常规呼吸支持组161例患者中的81例(50.3%)(风险差异,-3.1%[95%CI,-14.1%至7.8%];相对风险,0.94[95%CI,0.75-1.17])。两组之间在任何预设的次要终点均无显着差异。头盔无创通气组159例患者中有30例(18.9%)发生气压伤,常规呼吸支持组161例患者中有25例(15.5%)发生气压伤。头盔无创通气组159例中有5例(3.1%)发生皮肤压力损伤,常规呼吸支持组中161例中有10例(6.2%)发生皮肤压力损伤。头盔无创通气组发生2例严重不良事件,常规呼吸支持组发生1例。
这项研究的结果表明,与常规呼吸支持相比,头盔式无创通气并未显着降低COVID-19肺炎引起的急性低氧性呼吸衰竭患者的28天死亡率。然而,对结果的解释受到效果估计不精确的限制,这并不排除潜在的临床上重要的益处或伤害。
ClinicalTrials.gov标识符:NCT04477668。
Helmet noninvasive ventilation has been used in patients with COVID-19 with the premise that helmet interface is more effective than mask interface in delivering prolonged treatments with high positive airway pressure, but data about its effectiveness are limited.
To evaluate whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.
This was a multicenter, pragmatic, randomized clinical
trial that was conducted in 8 sites in Saudi Arabia and Kuwait between February 8, 2021, and November 16, 2021. Adult patients with acute hypoxemic respiratory failure (n = 320) due to suspected or confirmed COVID-19 were included. The final follow-up date for the primary outcome was December 14, 2021.
Patients were randomized to receive helmet noninvasive ventilation (n = 159) or usual respiratory support (n = 161), which included mask noninvasive ventilation, high-flow nasal oxygen, and standard oxygen.
The primary outcome was 28-day all-cause mortality. There were 12 prespecified secondary outcomes, including endotracheal intubation,
barotrauma, skin pressure injury, and serious adverse events.
Among 322 patients who were randomized, 320 were included in the primary analysis, all of whom completed the
trial. Median age was 58 years, and 187 were men (58.4%). Within 28 days, 43 of 159 patients (27.0%) died in the helmet noninvasive ventilation group compared with 42 of 161 (26.1%) in the usual respiratory support group (risk difference, 1.0% [95% CI, -8.7% to 10.6%]; relative risk, 1.04 [95% CI, 0.72-1.49]; P = .85). Within 28 days, 75 of 159 patients (47.2%) required endotracheal intubation in the helmet noninvasive ventilation group compared with 81 of 161 (50.3%) in the usual respiratory support group (risk difference, -3.1% [95% CI, -14.1% to 7.8%]; relative risk, 0.94 [95% CI, 0.75-1.17]). There were no significant differences between the 2 groups in any of the prespecified secondary end points.
Barotrauma occurred in 30 of 159 patients (18.9%) in the helmet noninvasive ventilation group and 25 of 161 (15.5%) in the usual respiratory support group. Skin pressure injury occurred in 5 of 159 patients (3.1%) in the helmet noninvasive ventilation group and 10 of 161 (6.2%) in the usual respiratory support group. There were 2 serious adverse events in the helmet noninvasive ventilation group and 1 in the usual respiratory support group.
Results of this
study suggest that helmet noninvasive ventilation did not significantly reduce 28-day mortality compared with usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. However, interpretation of the findings is limited by imprecision in the effect estimate, which does not exclude potentially clinically important benefit or harm.
ClinicalTrials.gov Identifier: NCT04477668.