High-flow Nasal Oxygen With or Without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (the HONOUR Pilot Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Among patients requiring intubation in each group, the number who were intubated according to the pre-specified criteria
研究概览
简要总结
This Randomized Control Trial will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with Acute Hypoxemic Respiratory Failure (AHRF).
详细描述
This is a pilot multicentre, concealed, stratified, permuted block randomized controlled trial enrolling patients with AHRF who are admitted to the intensive care unit. Patients with imminent need for intubation, or a contraindication to study interventions will be excluded. Patients will be randomized to receive either (1) sessions of at least 12 hours per day of helmet NIV oxygen interspersed with HFNO or (2) HFNO alone over at least 2 calendar days. Participants will be followed to hospital discharge or 60 days, with an additional quality of life assessment via telephone interview 6 months after 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
- •Intensive care unit admission (orders written)
- •Age ≥18 years
- •Hypoxemic acute respiratory failure for at least 1 hour and still present at time of screening for eligibility (symptom onset during last 14 days) with the following:
- •Respiratory rate >21bpm or clinical evidence of increased work of breathing and
- •Documented Hypoxemia defined as any one of:
- •i. PaO2:FiO2 < 300 ii. If no arterial blood gas available, then SpO2:FiO2 < 315 iii. Oxygen saturation <98% on FiO2 >= 0.4 or higher by Venturi mask, TAVISH mask 10 Litres / minute, or any non-invasive oxygenation strategy
- •Not already intubated or with tracheostomy
排除标准
- •Already on HFNO or other non-invasive ventilation strategy at FiO2>=0.4 for the last 24 hours in the ICU.
- •Immediate need for intubation (e.g., inadequate airway protection or refractory hypoxemia or cardiopulmonary arrest, massive hemoptysis, etc)
- •Extubated in the ICU within past 72 hours
- •Clinician deems that face mask NIV is indicated to treat a primary diagnosis of hypercapnic respiratory failure or acute congestive heart failure
- •Known neuromuscular disease
- •Patients being transitioned to Palliative care or unlikely to survive more than 24 hours
- •ICU discharge is planned or anticipated on the day of screening
- •Previously enrolled in this trial
- •Trauma patients who remain in a cervical spine collar at the time of recruitment or who have upper limb/torso fractures that would preclude them from safe application of the helmet
- •Clinician decision that positive pressure to face and/or nasal pharynx is a contraindication (eg. Transphenoidal surgery, basal skull fracture etc.)
研究组 & 干预措施
HFNO
High Flow Nasal Oxygen alone
干预措施: High Flow Nasal Oxygen (Device)
H-NIV
Helmet Non-Invasive ventilation for a minimum of 12 hours per day with HFNO between sessions
干预措施: Helmet Non-Invasive Ventilation (HNIV) (Device)
结局指标
主要结局
Among patients requiring intubation in each group, the number who were intubated according to the pre-specified criteria
时间窗: 2 years
Adherence to pre-specified criteria for intubation in each group
Time from ICU admission to randomization and initiation of treatment
时间窗: 2 years
Median time from ICU admission to randomization and initiation of the allocated treatment
Non-randomized Eligible Patients
时间窗: 2 years
Proportion of Eligible patients who are not randomized and reasons for this
Recruitment Rates
时间窗: 2 years
Recruitment rate at different study sites
Adherence/Compliance to Oxygenation Strategy
时间窗: 2 years
Rate of adherence to the assigned oxygenation strategy (and crossover rates)
次要结局
- Duration of non-invasive respiratory support after randomization up to 28 and 60 days(60 days)
- ICU length of stay(28 days)
- Number of participants in each group who need endotracheal intubation(28 and 60 days)
- All cause mortality(60 days)
- COVID-19 infection after hospitalization(28 days)
- Health related quality of life(180 days)
- Mortality at 180 days(180 days)
- Duration of invasive mechanical ventilation after randomization up to 28 and 60 days(28 and 60 days)
- Activities of Daily Living(180 days)
- Ventilator-Free Days to day 28, analyzed as an ordinal variable, with death = 0 days(28 days)