Comparison of High Flow Nasal Cannula (HFNC), Face-mask Non-Invasive Ventilation (NIV) & Helmet NIV in COVID-19 ARDS Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Rate of endotracheal intubation
研究概览
简要总结
Objective: To determine whether NIV delivered through helmet interface reduces intubation rate among patients with COVID-19 ARDS compared to face-mask NIV and HFNC.
Design, setting & participants: Two-center randomized clinical trial of 360 patients with mild to moderate ARDS and confirmed COVID-19 requiring non-invasive ventilation between August 2020 to January 2021. The patients with respiratory rate (RR) more than 30/min or oxygen saturation (SpO2) less than 90% or PaO2/FiO2 ratio less than 300 despite standard oxygen therapy by face mask (<15 L/min) who present to Royal hospital or Sultan Qaboos University Hospital (SQUH) emergency department, medical wards or intensive care unit (ICU).
Intervention: Patients will be randomly assigned (block randomization) to either face-mask NIV, HFNC or Helmet NIV. The helmet is a transparent hood that covers the entire head of the patient and has a rubber collar neck seal.
Main outcome and measures: The primary outcome is the rate of endotracheal intubation at 28-days. Secondary outcomes include hospital mortality at 28 and 90 days, NIV free days, invasive ventilator free days and hospital length of stay.
Expected results: We assume the failure rate of Helmet NIV to be 30%, failure rate of HFNC to be 40% and failure rate of face-mask NIV to be 50%. A sample size of 360 patients (120/group) will achieve a power of 0.90 at a significance level of 0.05. To account for 10% dropout rate, the total sample required is 396 subjects(132/group).
详细描述
Inclusion criteria:
- > 18 years of age
- confirmed COVID-19
- Within 48 hours of presentation in the emergency department, high dependency area or intensive care unit (ICU)
- ARDS according to Berlin definition (P/F < 300) or O2 saturation < 90% or RR > 30/min) in room air
- Standard oxygen therapy at flow rate < 15L/min x 60 minutes
Exclusion criteria:
- More than 48 hours of admission to the emergency room, high dependency or intensive care unit
- On non-invasive ventilation or HFNC for more than 4 hours before enrollement
- Impending cardiopulmonary arrest
- Need for immediate endotracheal intubation
- Hemodynamic instability or life-threatening arrhythmias
- GCS < 8
- Active intracranial pathology or high ICP
- Inability to cooperate or protect the airway
- Pregnancy
- Tracheostomy
- DNR or refusing intubation
- Known type 2 respiratory failure
- On chronic home oxygen therapy
Enrolment:
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
- 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
- •> 18 years of age
- •confirmed COVID-19
- •Within 48 hours of presentation in the emergency department, high dependency area or intensive care unit (ICU)
- •ARDS according to Berlin definition (P/F < 300) or O2 saturation < 90% or RR > 30/min) in room air
- •Standard oxygen therapy at flow rate < 15L/min x 60 minutes
排除标准
- •More than 48 hours of admission to the emergency department, high dependency or intensive care unit
- •More than 4 hours on NIV or HFNC before enrolment
- •Impending cardiopulmonary arrest
- •Need for immediate endotracheal intubation
- •Hemodynamic instability or life-threatening arrhythmias
- •Active intracranial pathology or high ICP
- •Inability to cooperate or protect the airway
- •Pregnancy
- •Tracheostomy
- •DNR or refusing intubation
- •Known type 2 respiratory failure
- •On chronic home oxygen therapy
结局指标
主要结局
Rate of endotracheal intubation
时间窗: within the study period with an average of one month.
The patient will be randomly assigned to one of the treatment arms. Then the patient will be followed up for one month for the primary outcome which is endotracheal intubation.
次要结局
- Hospital length of stay(Throughout the study completion. An average of 90 days.)
- Hospital mortality(90 days from the hospital mortality.)
- Ventilator free days(Throughout the study completion. An average of 90 days.)
研究者
Abdulhakeem Al-Hashim
Senior Consultant
Sultan Qaboos University