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The application of an oxygen mask, without supplemental oxygen, improved oxygenation in patients with severe COVID-19 already treated with high-flow nasal cannula
Critical Care ( IF 15.1 ) Pub Date : 2021-08-28 , DOI: 10.1186/s13054-021-03738-8
Besarta Dogani 1 , Fredrik Månsson 2, 3 , Fredrik Resman 2, 3 , Hannes Hartman 1, 4 , Johan Tham 2, 3 , Gustav Torisson 2, 3
Affiliation  

Trial registration ClinicalTrials, NCT04794400 Registered 12 March 2021—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04794400


Hypoxemia is the clinical hallmark of severe COVID-19 infection, and guidelines suggest using high-flow nasal cannula (HFNC) when conventional oxygen therapy fails [1, 2]. In late 2020, we observed that oxygenation could be improved in some patients by applying a mask (e.g. a nebulisation mask or simple oxygen mask) to ongoing HFNC. This procedure has quickly become a clinical routine at our hospital, and in this study, we aim to assess its effect.

The study was performed at Skåne university hospital in Malmö, Sweden. Eligibility criteria were (1) COVID-19 infection, (2) HFNC treatment, and (3) estimated PaO2/FiO2 ratio of ≤ 13 kPa (~ 97.5 mmHg). Baseline measurements, including arterial blood gases (ABG), were taken without mask. Then, a simple oxygen mask was applied over nose and mouth for 30 min, without supplemental oxygen, followed by another ABG. Patients maintained position and HFNC settings throughout the procedure, which was monitored by a study physician. After mask removal, SpO2 was recorded upon reaching steady state and participants could continue using the mask at their doctor’s discretion. The primary outcome was change in SaO2, with hypothesis testing through a paired t test. Secondary outcomes included changes in PaCO2, SpO2 and respiratory rate.

Eighteen patients were included, see Table 1. SaO2 (%) was higher in all patients after 30 min with mask than at baseline, mean difference: 5.1% (95%CI 3.0–7.2%), see Fig. 1a. There was a trend towards increased PaCO2, mean difference: 0.15 (95%CI − 0.03 to 0.34) KPa, see Fig. 1b. SpO2 increased with mask and decreased after mask removal, see Fig. 1c. Mean respiratory rate was 22.4 with mask, compared to 24.6 at baseline, mean difference: − 2.2, (95%CI − 0.2 to − 4.2).

Table 1 Patient and infection characteristics at the time of inclusion
Full size table
Fig. 1
figure1

Outcome. Mean oxygen saturation from arterial blood (SaO2) at baseline and with mask (a). Mean partial pressure of carbon dioxide (PaCO2) at baseline and with mask (b). Mean peripheral saturation from pulsoximetry (SpO2) at baseline, with mask and after mask removal (c) error bars = 95% confidence interval of the mean. *** = p < .001 from two-sided paired t test. Paired nonparametric tests were also performed to test robustness, with a similar degree of statistical significance (p < .001)

Full size image

Thus, this small study confirmed the observation that oxygenation improved when a mask was added to HFNC. PaCO2 increased slightly, possibly due to a lower respiratory rate, but without hypercapnia. No other side effects or complications were observed during this short-term study. The decline of SpO2 after mask removal suggested an intervention effect, although SpO2 did not fully reach baseline levels. The underlying mechanism was not studied, but we hypothesise that the mask could minimise entrainment of room air, especially when mouth-breathing.

Our HFNC device had a maximum flow rate of 40 L/min. However, the increase in SaO2 of 5% is in line with the 4% found in a study with a similar design but another HFNC device and a flow rate of 60 L/min [3]. Furthermore, this other study used a surgical mask, suggesting that the observed phenomenon is neither strictly mask- nor device-dependent. The study populations of these two small studies were quite similar though, and the generalisability of the results must be considered uncertain at this point.

Optimal intubation timing in COVID-19 is debated [4,5,6]. At our hospital, patients with severe hypoxemia have increasingly been managed for long periods on non-invasive respiratory support, including awake proning. In this context, the intermittent use of mask + HFNC (alternating with proning, during mobilisation, as a rescue in desaturation episodes, a bridge to intubation or a last resort for patients with ceiling of care) has filled a niche, being less demanding than NIV by face mask, while maintaining benefits of HFNC over conventional oxygen treatment. However, without experienced staff, rigorous monitoring and intubation protocols, adding a mask to HFNC could also delay intubation, putting the patient at risk.

In conclusion, further studies are needed regarding oxygen delivery in severe COVID-19. The results in this study suggest that the addition of a mask to HFNC could improve oxygenation in some patients in the short-term perspective. However, potential long-term risks, including those associated with delaying intubation, must be acknowledged.

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The authors thank Katja Beskow for assistance in data acquisition.

The study was funded by the Governmental Funding of Clinical Research within the Health Sciences (ALF). The funding body had no role in the design of the study, collection, analysis, and interpretation of data or in writing the manuscript.

Affiliations

  1. Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden

    Besarta Dogani & Hannes Hartman

  2. Department of Infectious Diseases, Skåne University Hospital, Ruth Lundskogs Gata 3, 20502, Malmö, Sweden

    Fredrik Månsson, Fredrik Resman, Johan Tham & Gustav Torisson

  3. Clinical Infection Medicine, Department of Translational Medicine, Lund University, Malmö, Sweden

    Fredrik Månsson, Fredrik Resman, Johan Tham & Gustav Torisson

  4. Department of Clinical Sciences Malmö, Lund University, Skåne University Hospital, Malmö, Sweden

    Hannes Hartman

Authors
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  5. Johan ThamView author publications

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  6. Gustav TorissonView author publications

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Contributions

BD collected the data, analysed data and drafted the manuscript. FR, FM, HH, and JT contributed to conception and design of the study and revised the manuscript. GT conceived the study, monitored data collection, analysed the data and revised the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Gustav Torisson.

Ethics approval and consent to participate

All patients provided informed consent and the study was approved by the Swedish Ethical Review Authority (2020-07078 and 2021-00834).

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Availability of data and materials

Data are available on reasonable request to the corresponding author.

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Dogani, B., Månsson, F., Resman, F. et al. The application of an oxygen mask, without supplemental oxygen, improved oxygenation in patients with severe COVID-19 already treated with high-flow nasal cannula. Crit Care 25, 319 (2021). https://doi.org/10.1186/s13054-021-03738-8

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中文翻译：
没有补充氧气的氧气面罩的应用改善了已经接受高流量鼻插管治疗的重症 COVID-19 患者的氧合

试验注册ClinicalTrials，NCT04794400 2021 年 3 月 12 日注册—追溯注册，https://clinicaltrials.gov/ct2/show/NCT04794400


低氧血症是严重 COVID-19 感染的临床标志，指南建议在常规氧疗失败时使用高流量鼻插管 (HFNC) [1, 2]。在 2020 年末，我们观察到，通过对正在进行的 HFNC 应用面罩（例如雾化面罩或简单氧气面罩）可以改善某些患者的氧合。该程序已迅速成为我们医院的临床常规，在本研究中，我们旨在评估其效果。

该研究在瑞典马尔默的斯科讷大学医院进行。合格标准是 (1) COVID-19 感染，(2) HFNC 治疗，以及 (3) 估计的 PaO2/FiO2 比率≤ 13 kPa (~ 97.5 mmHg)。基线测量，包括动脉血气（ABG），是在没有面罩的情况下进行的。然后，在鼻子和嘴巴上使用简单的氧气面罩 30 分钟，没有补充氧气，然后再进行一次 ABG。患者在整个手术过程中保持体位和 HFNC 设置，并由研究医师进行监测。去除面罩后，SpO2 在达到稳定状态时被记录下来，参与者可以根据医生的判断继续使用面罩。主要结果是 SaO2 的变化，通过配对 t 检验进行假设检验。次要结果包括 PaCO2、SpO2 和呼吸频率的变化。

包括 18 名患者，参见表 1。在佩戴面罩 30 分钟后，所有患者的 SaO2 (%) 均高于基线，平均差异：5.1% (95% CI 3.0–7.2%)，参见图 1a。PaCO2 有增加的趋势，平均差异：0.15（95%CI - 0.03 到 0.34）KPa，见图 1b。SpO2 随面罩增加而在去除面罩后降低，见图 1c。戴面罩时的平均呼吸频率为 22.4，而基线时为 24.6，平均差异：− 2.2，（95% CI − 0.2 到 − 4.2）。

表 1 纳入时的患者和感染特征
全尺寸表
图。1
图1

结果。基线时动脉血的平均氧饱和度 (SaO2) 和面罩 ( a )。基线和使用面罩 ( b ) 时二氧化碳的平均分压 (PaCO2 )。基线时脉搏血氧饱和度 (SpO2) 的平均外周饱和度，使用面罩和去除面罩后 ( c ) 误差线 = 95% 均值置信区间。*** =  p  < .001 来自两侧配对t检验。还进行了配对非参数检验以检验稳健性，具有相似程度的统计显着性 ( p  < .001)

全尺寸图片

因此，这项小型研究证实了当面罩添加到 HFNC 时氧合改善的观察结果。PaCO2 略有增加，可能是由于呼吸频率较低，但没有高碳酸血症。在这项短期研究中没有观察到其他副作用或并发症。尽管 SpO2 没有完全达到基线水平，但去除面罩后 SpO2 的下降表明存在干预作用。没有研究潜在的机制，但我们假设面罩可以最大限度地减少室内空气的夹带，尤其是在用嘴呼吸时。

我们的 HFNC 设备的最大流速为 40 L/min。然而，SaO2 增加 5% 与一项研究中发现的 4% 一致，该研究具有类似的设计，但使用另一个 HFNC 设备，流速为 60 L/min [3]。此外，另一项研究使用了外科口罩，这表明观察到的现象既不严格依赖于口罩，也不依赖于设备。尽管这两项小型研究的研究人群非常相似，但此时必须认为结果的普遍性尚不确定。

COVID-19 的最佳插管时间存在争议 [4,5,6]。在我们医院，越来越多的严重低氧血症患者长期接受无创呼吸支持，包括清醒俯卧撑。在这种情况下，间歇性使用面罩 + HFNC（在活动期间交替使用俯卧撑，作为去饱和度发作的抢救、插管的桥梁或对有护理上限的患者的最后手段）填补了一个利基市场，要求低于面罩 NIV，同时保持 HFNC 优于传统氧气治疗的优势。然而，如果没有经验丰富的工作人员、严格的监测和插管协议，在 HFNC 中添加面罩也可能延迟插管，使患者处于危险之中。

总之，需要进一步研究严重 COVID-19 中的氧气输送。本研究的结果表明，从短期来看，在 HFNC 中添加面罩可以改善某些患者的氧合。然而，必须承认潜在的长期风险，包括与延迟插管相关的风险。

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    Berlin DA、Gulick RM、Martinez FJ。严重的 Covid-19。N Engl J Med。2020;383(25):2451-60。

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    Montiel V、Robert A、Robert A、Nabaoui A、Marie T、Mestre NM 等。高流量鼻插管顶部的外科面罩可改善 COVID-19 低氧性呼吸衰竭危重患者的氧合。安重症监护室。2020；10(1):125。

    文章 谷歌学术

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    Tobin MJ、Jubran A、Laghi F. COVID-19 患者的低氧血症不需要气管插管。对 Br J Anaesth 2021 的评论；126：44-7。Br J Anaesth。2021;126(2):e75-6。

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    Papoutsi E、Giannakoulis VG、Xourgia E、Routsi C、Kotanidou A、Siempos II。插管时间对 COVID-19 危重患者临床结果的影响：非随机队列研究的系统评价和荟萃分析。暴击护理。2021;25(1):121。

    文章 谷歌学术

下载参考

作者感谢 Katja Beskow 在数据采集方面的帮助。

该研究由政府卫生科学临床研究基金 (ALF) 资助。资助机构在研究设计、收集、分析和数据解释或撰写手稿方面没有任何作用。

隶属关系

  1. 瑞典马尔默斯科讷大学医院内科

    贝萨塔·多加尼和汉内斯·哈特曼

  2. 传染病科，斯科讷大学医院，Ruth Lundskogs Gata 3, 20502, Malmö, Sweden

    Fredrik Månsson、Fredrik Resman、Johan Tham 和 Gustav Torisson

  3. 瑞典马尔默隆德大学转化医学系临床感染医学

    Fredrik Månsson、Fredrik Resman、Johan Tham 和 Gustav Torisson

  4. 马尔默临床科学系，隆德大学，斯科讷大学医院，马尔默，瑞典

    汉斯·哈特曼

作者
  1. Besarta Dogani查看作者出版物

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贡献

BD 收集了数据，分析了数据并起草了手稿。FR、FM、HH 和 JT 为研究的构思和设计做出了贡献，并修订了手稿。GT 构思了研究、监测数据收集、分析数据并修改了手稿。所有作者阅读并认可的终稿。

通讯作者

与古斯塔夫·托里森的通信。

伦理批准和同意参与

所有患者都提供了知情同意，并且该研究获得了瑞典伦理审查机构的批准（2020-07078 和 2021-00834）。

同意发表

不适用。

利益争夺

作者声明没有竞争利益。

数据和材料的可用性

数据可向通讯作者提出合理要求。

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Dogani, B.、Månsson, F.、Resman, F.等。没有补充氧气的氧气面罩的应用改善了已经用高流量鼻插管治疗的重症 COVID-19 患者的氧合。暴击护理 25, 319 (2021)。https://doi.org/10.1186/s13054-021-03738-8

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