The Effects of Two Systems Above Low-flow Nasal Cannula on Arterial Oxygen Tension in Patients With COVID-19 : Surgical Face Mask Versus Double-trunk Mask
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Changes in PaO2
研究概览
简要总结
This study will compare the impact of two systems above low-flow nasal cannula on the arterial oxygen tension in patients with COVID-19. The two systems are the Surgical Mask (SM) and the Double-Trunk Mask (DTM).
详细描述
Hospitalized patients with COVID-19 typically present with hypoxemia. In some patients, hypoxemia can be corrected with low flow nasal cannula. When placed above nasal cannula, some systems have demonstrated their interest in improving the performance of patient's oxygen delivery. For example, two recent studies have shown that adding a Double-Trunk Mask (DTM) or Surgical Mask (SM) above nasal cannula has the potential to improve the PaO2 despite no change in oxygen output (Duprez et al., J Clin Monit Comput 2020; Montiel et al., Ann Intensive Care 2020). However, there is no study comparing the relative effectiveness of these 2 systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •COVID-19 positive
- •SpO2 between 92 and 96% with low-flow oxygen therapy
- •Oxygen output at baseline between 3 and 7 L/min.
排除标准
- •Pulmonary disease with hypercapnia
- •Confusion
- •Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
研究组 & 干预措施
Low-flow nasal cannula
The standard oxygen delivery system (low-flow nasal cannula) is worn by the patient, without the DTM or the SM
干预措施: Standard Oxygen Delivery System (Other)
Double-Trunk Mask
The Double-Trunk Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).
干预措施: Double-Trunk Mask (Other)
Surgical Mask
The Surgical Mask is placed above the standard oxygen delivery system (low-flow nasal cannula).
干预措施: Surgical Mask (Other)
结局指标
主要结局
Changes in PaO2
时间窗: At baseline and 30 minutes after wearing the randomized oxygen delivery system
Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system
次要结局
- Change in O2 output(At 30 minutes and 60 minutes after wearing the randomized oxygen delivery system)
- Change in pH(At baseline and 30 minutes after wearing the randomized oxygen delivery system)
- Change in PaCO2(At baseline and 30 minutes after wearing the randomized oxygen delivery system)
- Change in respiratory rate(At baseline, 30 minutes and 60 minutes after wearing the randomized oxygen delivery system)
- Change in dyspnea(At baseline and 60 minutes after wearing the randomized oxygen delivery system)
研究者
Poncin
Principal Investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain