Effect of eCASH Concept Combined With Early Goal-Directed Mobilization in Preventing ICU-Acquired Weakness in Mechanically Ventilated ICU Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of ICU-Acquired Weakness
研究概览
简要总结
This single-center, prospective, randomized controlled trial aims to evaluate whether an eCASH concept-based analgesia and sedation strategy combined with early goal-directed mobilization can reduce the incidence of intensive care unit-acquired weakness (ICU-AW) in mechanically ventilated ICU patients. A total of 70 adult patients receiving invasive mechanical ventilation will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive routine ICU nursing care plus an eCASH-based analgesia and sedation strategy combined with early goal-directed mobilization, while the control group will receive routine ICU nursing care. The primary outcome is the incidence of ICU-AW. Secondary outcomes include total doses of remifentanil and midazolam, respiratory function after extubation, duration of mechanical ventilation, and adverse events.
详细描述
Intensive care unit-acquired weakness (ICU-AW) is a common complication in critically ill patients receiving invasive mechanical ventilation. It may prolong mechanical ventilation, delay recovery, increase the risk of complications, and impair long-term functional outcomes. Both optimized analgesia-sedation management and early mobilization are considered important strategies for reducing ICU-AW, but evidence regarding their combined application remains limited.
This study is a single-center, prospective, randomized, parallel-group, single-blind controlled trial. Eligible adult ICU patients receiving invasive mechanical ventilation will be randomly assigned to either the intervention group or the control group. The control group will receive routine ICU nursing care, including routine analgesia and sedation management, vital sign monitoring, airway care, skin care, psychological support, muscle strength assessment, and early activity after clinical stabilization.
The intervention group will receive routine ICU nursing care plus an eCASH concept-based analgesia and sedation strategy combined with early goal-directed mobilization. The eCASH-based strategy emphasizes early combined intervention, patient comfort, analgesia-first management, minimization of sedative exposure, and humanistic care. A multidisciplinary team will assess each patient and develop individualized analgesia, sedation, comfort, and rehabilitation plans. Early goal-directed mobilization will be adjusted according to the patient's clinical condition, functional status, and tolerance, and may include passive or active limb exercises, balance training, bedside cycling exercise, and transcutaneous electrical stimulation.
The intervention will begin after enrollment in the ICU and continue until transfer out of the ICU. Outcome assessors and statistical analysts will be blinded to group allocation. The study aims to determine whether the combined eCASH and early goal-directed mobilization strategy can reduce the incidence of ICU-AW and improve respiratory and clinical recovery in mechanically ventilated ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors responsible for ICU-acquired weakness diagnosis and respiratory function assessment, as well as statistical analysts, will be blinded to group allocation. Participants and care providers will not be blinded because of the nature of the nursing and mobilization intervention.
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
- •Patients admitted to the ICU who require invasive mechanical ventilation and have a mechanical ventilation duration of at least 48 hours.
- •Age 18 years or older.
- •Patients who are not undergoing secondary intubation.
- •Patients with relatively stable organ function.
- •Written informed consent provided by the patient's family member or legally authorized representative.
排除标准
- •Patients in the acute stress phase with hemodynamic instability, including severe patient-ventilator asynchrony, severe traumatic brain injury with intracranial hypertension, status epilepticus, or after cardiopulmonary resuscitation.
- •Patients with severe acute respiratory distress syndrome.
- •Patients with neurological diseases, organic neurological lesions, or neurological injury.
- •Patients with a history of psychiatric disease.
- •Patients with complications causing altered mental status and inability to cooperate, such as hepatic encephalopathy or pulmonary encephalopathy.
- •Patients diagnosed with myasthenia gravis.
- •Patients with a history of psychoactive drug abuse, illicit drug use, or alcohol abuse.
结局指标
主要结局
Incidence of ICU-Acquired Weakness
时间窗: At transfer out of the ICU
ICU-acquired weakness will be assessed using the Medical Research Council muscle strength score. Six bilateral muscle groups will be evaluated, including shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion. A total score of less than 48 will be considered diagnostic of ICU-acquired weakness.
次要结局
- Total Dose of Remifentanil(From enrollment to transfer out of the ICU, assessed up to 6 months)
- Total Dose of Midazolam(From enrollment to transfer out of the ICU, assessed up to 6 months)
- Forced Vital Capacity After Extubation(Within 24 hours after extubation)
- Peak Expiratory Flow After Extubation(Within 24 hours after extubation)
- Duration of Mechanical Ventilation(From initiation of mechanical ventilation to successful discontinuation, assessed up to 6 months)
研究者
Qianru Lin
Principal Investigator
The First Affiliated Hospital of Soochow University