ZEPHYR: Multicenter, Prospective, Randomized, Open-label Study in Consecutive Patients Hospitalized for Acute Respiratory Failure Requiring Mechanical Ventilation With Endotracheal Tube. This Study Compared Two Ventilation Modes: NAVA Mode and Spontaneous Breathing With Inspiratory Pressure Support (the Latter is Considered as the Reference Ventilation Mode).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Clinact
- 入组人数
- 129
- 试验地点
- 22
- 主要终点
- Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.
研究概览
简要总结
This is a multicenter, prospective, randomized, open-label study which compared two ventilation modes: spontaneous NAVA mode and spontaneous breathing with IPS mode (the latter is considered as the reference ventilatory mode) in patients admitted to the ICU for acute respiratory failure and ventilated with an endotracheal tube. NAVA mode allows to minimize patient-ventilator disharmony with acceptable tolerance and to preserve spontaneous ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient ventilated with endotracheal tube for more than 24 hours
- •Return for at least 30 minutes to spontaneous ventilation allowing IPS with a level of pressure support <30 cm H2O;
- •Level of sedation =< 4 on the Ramsay scale in the absence of medical decision to increase the level of sedation;
- •Fraction of inspired oxygen (FiO 2) =< 50% with a positive end-expiratory pressure (PEEP) =< 8 cm H2O;
- •Absence of administration of high-dose vasopressor therapy defined by:
- •norepinephrine > 0.3 mcg / kg / min;
- •dopamine > 10 mcg / kg / min;
- •Estimated duration of mechanical ventilation > 48h00
排除标准
- •Contraindication to the implementation of the NAVA endotracheal tube, ie any contraindication to the implementation of a gastric tube or to the repositioning of a tube already in place:
- •Recent gastrointestinal suture ;
- •Esophageal varices rupture with gastrointestinal bleeding within 4 days prior to inclusion;
- •Therapeutic limitation or active treatment discontinuation;
- •Pregnant women;
- •Protected adults;
- •Patient already included in the study;
结局指标
主要结局
Evaluate the benefit of NAVA mode as compared to IPS mode in terms of duration of spontaneous ventilation 48 hours after inclusion.
时间窗: Continuous recording during 48 hours following the intubation
The time spent in different modes of spontaneous ventilation (NAVA, IPS) and controlled ventilation (VAC controlled pressure) will be measured. The primary endpoint will be the proportion of patients remaining in spontaneous ventilation after the first 48 hours.
次要结局
- Reduction of patient / ventilator disharmony, measured during the first 48 hours with the disharmony index(Continuous recording during the first 48 hours)
- Real-time spent in NAVA mode and frequency of returns in a controlled mode (controlled ventilation VAC).(Continuous recording during the first 48 hours)
- Earnings on the "breathing comfort"(Continuous recording during the first 48 hours)
- Earnings on sleep architecture(Continuous recording during the first 48 hours)
- Tolerance(Continuous for the duration of ICU stay, an expected maximum of 14 days)