RolE of High Velocity Nasal Insufflation in imrpoVing wEaning Success in Respiratory Failure Patients (REVIVER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Failure of HVNI / NIPPV within 72 hours of initiation
研究概览
简要总结
The goal of this randomized active-controlled study is to investigate the role of high velocity nasal insufflation (HVNI) in the immediate post-extubation period and compare it with non-invasive positive pressure ventilation (NIPPV) as regards to weaning success rate. The study will recruit those who have been on invasive mechanical ventilation for at least 3 days and with a high risk of weaning failure.
详细描述
This is a single center prospective randomized controlled open label trial of high velocity nasal insufflation (HVNI) in the immediate post-extubation period versus noninvasive positive pressure ventilation (NIPPV). After at least 72 hours from intubation, for respiratoy failure, those who are considered to be eligible for weaning from mechanical ventilation based on the weaning protocol but are at high risk for extubation failure will be randomized to either HVNI or NIPPV. Data on the respiratory and cardiovascular status will be continuously monitored and recorded thereafter.
The primary outcome measure will be failure of either arm within 72 hours of initiation, leading to reintubation (or crossover only from a failed HVNI allocation to NIV based on clinical judgement to avoid reintubation in selected cases). Secondary outcomes to be investigated include: 1) Failure of HVNI or NIPPV after 72 hours from initiation, 2) hospital mortality, 3) length of ICU stay, 4) length of hospital stay, 5) incidence of ventilator associated pneumonia, 6) patient tolerance and comfort, and 7) ICU readmission or mortality at 28-days post hospital discharge.
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
- •High risk of extubation failure (one or more of the following):
- •Age >65 years old
- •APACHE II score at extubation >12
- •≥2 comorbidities
- •Endotracheal intubation > 7 days
- •≥1 failed attempts at disconnection from mechanical ventilation
- •Chronic lung disease e.g., COPD, OHS, etc.
- •Underlying left ventricular dysfunction
- •Non-minimal airway secretions
排除标准
- •Non-respiratory failure patients
- •Patients judged to need a tracheostomy (poor airway reflexes or copious secretions)
- •Patients who cannot tolerate an oral or nasal interface (facial trauma or perforated nasal septum)
- •Patients with increased risk of aspiration, agitation, or uncooperativeness
- •End stage disease with life expectancy less than 6 months
结局指标
主要结局
Failure of HVNI / NIPPV within 72 hours of initiation
时间窗: within 72 hours from start of either allocated modality
need to withdraw allocated respiratory support modality based on predefined arm failure criteria
次要结局
- Failure of HVNI / NIPPV after 72 hours of initiation(beyond 72 hours from start of either allocated modality)
- Length of Hospital stay(Through study completion, an average of 1 year)
- Patient tolerance and comfort(within 72 hours from start of either allocated modality)
- Hospital Mortality(Through study completion, an average of 1 year)
- Length of ICU stay(Through study completion, an average of 1 year)
- Incidence of ventilator associated pneumonia (VAP)(beyond 48 hours from start of invasive mechanical ventilation)
- ICU readmission or mortality post hospital discharge(28 days after hospital discharge)
研究者
Ahmed Salama Sadaka
Lecturer
Alexandria University