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临床试验/NCT04794400
NCT04794400已完成不适用

The Application of a Mask in Patients With Severe Covid-19 Already Treated With High-flow Nasal Cannula.

Region Skane1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Region Skane
入组人数
18
试验地点
1
主要终点
Oxygenation

研究概览

简要总结

Patients with severe hypoxemic respiratory failure due to Covid-19 are often treated with oxygen delivered through a high-flow nasal cannula (HFNC). This is according to guidelines. We have made the clinical observation that oxygenation sometimes improves when a mask (e.g. oxygen mask or inhalation mask) is applied on top of the HFNC. This has quickly become a clinical routine at intermediary care units at our hospital, where patients with HFNC are offered to test the intervention (mask + HFNC) as part of clinical routine.

This study aims to evaluate this new routine in a standardised way.

详细描述

Patients with severe covid-19, treated with HFNC, will be approached for consent. If inclusion critera and no exclusion criteria are fulfilled, baseline measurements will be taken without mask, including arterial blood gas analysis (ABG)

Then a simple oxygen mask will be applied covering nose and mouth, without providing supplemental oxygen. After 30 minutes with mask + HFNC, new measurements will be taken, including ABG.

After 30 minutes, the mask is removed and when steady state occurs, new measurements will be taken, without ABG. Then, the patients could continue using the mask as part of clinical routine

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Verified Covid19 infection
  • •treatment with HFNC
  • •Estimated P/F ratio of ≤ 13 KPa

排除标准

  • •language barrier
  • •unable to provide consent
  • •risk of deterioration due to study

研究组 & 干预措施

Intervention

Experimental

An additional oxygen mask was applied for 30 minutes, in patients with ongoing HFNC treatment.

干预措施: oxygen mask (Other)

结局指标

主要结局

Oxygenation

时间窗: 30 minutes

Change in SaO2 in % from ABG with mask vs without mask

次要结局

  • Carbon dioxide(30 minutes)
  • SpO2(60 minutes)
  • Respiratory rate(30 minutes)

研究者

发起方
Region Skane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gustav Torisson

Principal Investigator

Region Skane

研究点 (1)

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