NCT06677099尚未招募不适用
Electrical Impedance Tomography in Guiding Early and Precise Rehabilitation of Patients with Difficult Ventilator Weaning:A Single-cente Randomised Controlled Trial
Capital Medical University0 个研究点目标入组 80 人开始时间: 2024年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- peak expiratory flow
研究概览
简要总结
Diaphragm dysfunction, ineffective chest wall and respiratory muscle function are frequently observed in critically ill patients with difficult weaning from mechanical ventilation(MV).It is the leading cause of retention of airway secretions and insufficient airway clearance.Thechest physiotherapy (CPT) of critically ill patients can reduce secretion retention. We designed a protocol to investigate the feasibility and efficacy of CPT guided by electrical impedance tomography (EIT) in Difficult-to-Wean patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •mechanical ventilation patients who are ≥18 years old, are received to invasive mechanical ventilation more than 96 hours before randomization, are meted the preconditions for the machine to be withdrawn, and at least have one failed attempt to withdraw the ventilator (re-need ventilator support within 48 hours after extubation),
- •willing to participate in the study and sign the informed consentsent.
排除标准
- •Malignant arrhythmia or acute myocardial ischemia
- •Pneumothorax, pulmonary bulla and barotrauma and other lung diseases
- •Hemorrhagic disease or abnormal coagulation mechanism with bleeding tendency
- •Chest skin trauma
- •Pulmonary hypertension and pulmonary embolism
- •With a permanent or temporary pacemaker
- •There is malignant tumor
- •Present and previous history of neuromuscular diseases affecting respiratory muscle
- •Participated in another clinical study related to mechanical ventilation withdrawal
- •Can not cooperate with the study for any reason or the researcher thinks that it is not suitable to be included in this experiment.
结局指标
主要结局
peak expiratory flow
时间窗: All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3)
次要结局
- The cumulative incidence of successful weaning by Day 30(from admission to discharge, assessed up to 1 day)
- Maximum inspiratory pressure(All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3))
- Diaphragm thickening rate(All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3))
- Diaphragmatic excursion(All data will be recorded at the baseline (T1), 14 days (T2) and 28 days (T3))
- Length of ICU stay(from admission to discharge, assessed up to 1 day)
- Cumulative incidence for death before successful weaning(from admission to discharge, assessed up to 1 day)
研究者
Jingyi Ge
Principal Investigator
Capital Medical University
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