Effect of Neurally-Adjusted Ventilatory Assist (NAVA) on Weaning Outcome in Patients With Mechanical Ventilation: Multicenter, Single-blind, Parallel, Control, Randomized Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- The 28-day ventilator-free days
研究概览
简要总结
This study intends to compare the effects of NAVA and PSV on weaning success rate and mechanical ventilation time in patients with tracheotomy patients through a randomized controlled study.
详细描述
For patients with difficult weaning, NAVA can shorten the time of mechanical ventilation, but there is no large-scale study to explore the effect of NAVA on the weaning success rate and mechanical ventilation time of patients with gas resection. Therefore, this study intends to compare the effects of NAVA and PSV on weaning success rate and mechanical ventilation time in patients with tracheotomy patients through a randomized controlled study.
It is a prospective, multicenter, parallel group, single blind, randomized controlled tria。
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tracheotomy and invasive mechanical ventilation is expected to be required for > 48h;
- •When support pressure ≤ 15 cmH2O, it can withstand pressure support ventilation (PSV) time > 1h;
排除标准
- •Age < 18 years or > 85 years;
- •Deep sedation.
- •Severe hemodynamic instability (norepinephrine or equivalent converted dose of other vasoactive drugs > 1ug / kg.min or map ≤ 65mmhg)
- •Severe respiratory center depression, high paraplegia, neuromuscular disease;
- •Esophageal obstruction, esophageal perforation, severe esophageal variceal bleeding, upper gastrointestinal surgery, diaphragmatic hernia and thoracic deformity;
- •Patients with chronic respiratory diseases requiring long-term home oxygen therapy;
- •Patients with severe coagulation dysfunction (INR > 1.5, APTT > 44s, history of leukemia);
- •Severe other organ dysfunction is expected to die in a short time (7 days) or palliative treatment.
- •The estimated survival time of advanced solid organ or hematological system tumors is < 30 days
- •Participate in other clinical studies within 30 days;
- •Failing to sign the informed consent form;
研究组 & 干预措施
NAVA
Received NAVA.
干预措施: NAVA (Device)
PSV
Received PSV.
干预措施: PSV (Device)
结局指标
主要结局
The 28-day ventilator-free days
时间窗: From enrollment to days 28
Days alive and free from mechanical ventilation from study drug administration to day 28.
次要结局
- 28-ICU mortality(From enrollment to days 28.)
- Duration of Mechanical Ventilation(From enrollment to days 28.)
- Weaning Success Rate(From enrollment to days 28)
研究者
Ling Liu
professor
Southeast University, China