Noninvasive Ventilation Breathing Test Guiding Sequential Invasive and Noninvasive Ventilation Weaning of Patients With Acute Hypoxic Respiratory Failure: a Randomized, Multicenter, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Weaning time
研究概览
简要总结
SBT, as a routine extubation strategy for invasive mechanical ventilation, has been widely recognized. However, in recent years, studies have found that SBT may lead to delayed extubation, which has been confirmed in COPD patients but has not yet been widely accepted in patients with acute hypoxic respiratory failure. Both invasive mechanical ventilation and non-invasive mechanical ventilation are positive pressure ventilation, with the essential difference being the human-machine interface. The safe inspiratory pressure for non-invasive mechanical ventilation should not exceed 20cmH2O (1cmH2O=0.098 kPa). If the cause of respiratory failure is relieved or removed, respiratory function improves, and the patient has good airway protection ability and can tolerate non-invasive ventilation, the endotracheal tube can be removed as soon as possible to switch to non-invasive mechanical ventilation, thereby shortening the time of invasive mechanical ventilation and reducing the risk of complications. This study trial aims to identify the timing of early extubation sequential non-invasive mechanical ventilation in patients with acute hypoxic respiratory failure through non-invasive ventilation breathing tests, providing a basis for updating the process of invasive mechanical ventilation extubation.
详细描述
All the patients included will be randomly assigned to receive Non Invasive Ventilation Breathing Test protocol or SBT protocol.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who have been admitted to the intensive care unit (ICU) with Acute Hypoxic Respiratory Failure. Oxygenation index less than 300mmHg, have undergone tracheal intubation, and are anticipated received invasive mechanical ventilation for more than 24 hours.
排除标准
- •• Age over 80 years,
- •Pregnancy,
- •Consciousness disorders or intracranial hypertension caused by various reasons,
- •Neuromuscular disorders,
- •Severe cardiac dysfunction (New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachycardia),
- •Cardiogenic shock or after major cardiac surgery,
- •Severe liver and kidney failure,
- •Severe malnutrition,
- •Injury to the upper airway or nose and face, making it impossible to wear a nose (face) mask,
- •Severe agitation, Severe agitation, expected to be unable to cooperate with non-invasive mechanical ventilation.
研究组 & 干预措施
Assigned Interventions
Noninvasive Ventilation Breathing Test guiding sequential invasive Ventilation and noninvasive ventilation weaning group with Ventilators.
干预措施: Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol (Procedure)
The standard SBT guiding weaning group
The standard SBT guiding weaning protocol with Ventilators.
干预措施: The standard SBT guiding weaning group (Procedure)
结局指标
主要结局
Weaning time
时间窗: From the date when the patient meets the weaning screening criteria until the date of extubation, assessed up to 28 days.
Weaning time in hours is defined as the time period from the date when the patient meets the weaning screening criteria until the date of extubation.
次要结局
- Respiratory parameters at baseline, day 1, 3, and 7(From enrollment to Day7.)
- Other outcomes: length of ICU stay and length of hospital stay(From the date of enrollment until the date of discharge, assessed up to 1 year.)
- Arterial blood gas analysis parameters at baseline, day 1, 3, and 7(From enrollment to Day 7.)
- Hemodynamic parameters at baseline, day 1, 3, and 7(From enrollment to Day7)
- Other outcomes: ICU mortality and in-hospital mortality(From the date of enrollment until the date of discharge, assessed up to 1 year.)
- Adverse events(From date of enrollment until the date of transfer out of ICU, assessed up to 3 months.)
- Administration and quality of analgesia and sedation.(From enrollment until extubation, assessed up to 2 weeks.)
- RASS scores(From enrollment until extubation, assessed up to 2 weeks.)
- EIT data(From the time when patients are ready for SBT trial until 1h after extubation, assessed up to 1 week.)
研究者
Kang Yan
The Chair of West China of Tian Hoapital
West China Hospital