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[JAMA发表论文]:头盔式无创通气与高流量鼻导管氧疗对伴有中重度低氧性呼吸功能衰竭的新冠肺炎患者无呼吸支持天数的影响
2021年04月28日 时讯速递, 进展交流 暂无评论

Original Investigation Caring for the Critically Ill PatientMarch 25, 2021

Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial

Domenico Luca Grieco, Luca S. Menga, Melania Cesarano, et al

JAMA. Published online March 25, 2021. doi:10.1001/jama.2021.4682

Abstract

Importance 背景

High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19.

高流量鼻导管氧疗被推荐作为急性低氧性呼吸功能衰竭的初始治疗,且广泛应用于新冠肺炎患者。

Objective 目的

To assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone.

评估与单纯使用高流量鼻导管氧疗相比,头盔式无创通气能否增加新冠肺炎患者不使用呼吸支持的天数。

Design, Setting, and Participants 设计,场景及研究对象

Multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200).

2020年10月至12日在意大利4个ICU进行的多中心随机临床试验,纳入109名合并中重度低氧性呼吸功能衰竭(PaO2/FiO2 ≤ 200)的新冠肺炎患者,最后随访日期为2021年2月11日。

Interventions 干预措施

Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H2O; pressure support, 10-12 cm H2O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55).

入选患者随机分组,分别接受头盔式无创通气(PEEP, 10-12 cm H2O; PS, 10-12 cm H2O)至少48小时后序贯为高流量鼻导管氧疗 (n = 54) 或单纯使用高流量鼻导管氧疗 (60 L/min) (n = 55)。

Main Outcomes and Measures 主要预后指标

The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment, the number of days free of invasive mechanical ventilation at day 28, the number of days free of invasive mechanical ventilation at day 60, in-ICU mortality, in-hospital mortality, 28-day mortality, 60-day mortality, ICU length of stay, and hospital length of stay.

主要预后指标为入选后28天内无呼吸支持的天数。次要预后指标包括28天内需要气管插管的患者比例,28天内无有创机械通气天数,60天内无有创机械通气天数,ICU及住院病死率,28天及60天病死率,ICU住院日及总住院日。

Results 结果

Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, −2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference. The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, −21% [95% CI, −38% to −3%]; P = .03). The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04). The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, −1% [95% CI, −17% to 15%]; P > .99).

共110名患者接受随机分组,109名 (99%) 患者完成试验(中位年龄, 65 岁 [四分位区间 {IQR}, 55-70]; 21 名女性 [19%])。头盔组随机分组后28天内无呼吸支持中位天数为 20 (IQR, 0-25) 天,高流量鼻导管氧疗组为 18 (IQR, 0-22) 天,无统计学差异(平均差异, 2 天 [95% CI, −2 to 6]; P = .26)。在9项预先确定的次要预后指标中,7项没有统计学差异。头盔组气管插管比例显著低于高流量鼻导管氧疗组(30% vs 51%; 差异, −21% [95% CI, −38% to −3%]; P = .03)。头盔组28天内无有创机械通气中位天数显著高于高流量鼻导管氧疗组(28 [IQR, 13-28] vs 25 [IQR 4-28]; 平均差异, 3 天 [95% CI, 0-7]; P = .04)。头盔组住院病死率24%,高流量鼻导管氧疗组为 25%(绝对差异, −1% [95% CI, −17% to 15%]; P > .99)。

Conclusions and Relevance 结论与意义

Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation.

对于伴有中重度低氧血症的新冠肺炎患者,与高流量鼻导管氧疗相比,采用头盔式无创通气治疗不显著改变28天哪无呼吸支持天数。需要进一步研究确定对于其他结局包括气管插管需求的影响。

Trial Registration

ClinicalTrials.gov Identifier: NCT04502576

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