Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in O2 output
研究概览
简要总结
This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.
详细描述
The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.
Each included patient will wear standard nasal cannula in addition to the Double-Trunk Mask for 30 minutes, then only their standard oxygen interface for the next 30 minutes. While maintaining the oxygen saturation by pulse oximetry (SpO2) at a target value of 94%, the impact of the DTM will be assessed by measuring the change of oxygen flow given to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •SpO2 between 92 and 96% with low-flow oxygen therapy (< 15 L/min).
排除标准
- •Chronic obstructive pulmonary disease or other chronic respiratory disease
- •Confusion
- •Hypoxemia corrected (SpO2 ≥ 96%) with O2 flow ≤ 3 L/min
- •Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)
结局指标
主要结局
Change in O2 output
时间窗: At baseline and 30 minutes after wearing both systems
The O2 output will be adjusted to maintain a SpO2 of 94% using both systems for administering O2. The O2 flow will be read from the position of the ball in flow meters.
次要结局
- Changes in PaCO2(At baseline and 30 minutes after wearing DTM)
- Changes in PaO2(At baseline and 30 minutes after wearing DTM)
- Changes in pH(At baseline and 30 minutes after wearing DTM)
- Changes in respiratory rate(At baseline and 30 minutes after wearing both systems)
- Comfort with the interfaces(30 minutes after wearing both systems)
研究者
Poncin
Principal Investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain