Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Ventilator-Free Days (VFD)
研究概览
简要总结
We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.
详细描述
A detailed description can be found in the study protocol published in Trials in Dec 2020:
Tverring, J., Åkesson, A. & Nielsen, N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials 21, 994 (2020). https://doi.org/10.1186/s13063-020-04863-5
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •(all of the following):
- •Age ≥ 18 years
- •Sars-Cov-2 found in the upper or lower respiratory tract by PCR during the current disease episode
- •Peripheral oxygen saturation (SpO2) < 92 % despite conventional low-flow oxygen therapy of at least 6 L /min for at least 15 min
- •A decision to initiate HFNC or Helmet CPAP by the attending ward physician
- •The patient has given written informed consent to participate.
排除标准
- •(any of the following):
- •Need for direct admission to the intensive care unit for mechanical ventilation
- •Unconsciousness or drowsiness
- •Pneumothorax
- •Carbon dioxide pressure (pCO2) > 6 kPa in venous blood gas (VBG)
- •Underlying chronic obstructive pulmonary disease stage III-IV
- •A decision not to participate
- •Inability to comprehend the study content and give informed consent
研究组 & 干预措施
Helmet CPAP
Helmet Continuous Positive Airway Pressure (CaStar hood for CPAP therapy by Starmed/Intersurgical) driven by high-flow blender (Bio-Med Devices).
干预措施: Helmet CPAP (Device)
HFNC
High-Flow Nasal Cannula (OptiflowTM nasal high-flow interface) driven by AIRVO 2 humidification system (Fisher and Paykel)
干预措施: HFNC (Device)
结局指标
主要结局
Ventilator-Free Days (VFD)
时间窗: 28 days
Number of days alive and free of mechanical ventilation within 28 days. Patients who die within 28 days will be counted as 0 VFD. Time in ventilator will be counted in hours and rounded to whole days.
次要结局
- SpO2/FiO2-ratio(1 hour after randomisation)
- Patient comfort(24 hours after randomisation)
- Frequency of endotracheal intubation(28 days)
- Frequency of carbon dioxide rebreathing(28 days)
- Days alive within(28 days and 180 days)