eCASH and Early Goal-Directed Mobilization to Prevent ICU-Acquired Weakness (eCASH-EGDM)
Effect of eCASH Concept Combined With Early Goal-Directed Mobilization in Preventing ICU-Acquired Weakness in Mechanically Ventilated ICU Patients: A Randomized Controlled Trial
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Jiangsu
-
Suzhou、Jiangsu、中国、215006
- The First Affiliated Hospital of Soochow University
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：eCASH Plus Early Goal-Directed Mobilization
Participants in this arm will receive routine ICU nursing care plus an eCASH concept-based analgesia and sedation strategy combined with early goal-directed mobilization.
The intervention includes comfort-focused care, analgesia-first management, minimal sedation, humanistic care, and individualized progressive mobilization from ICU admission until transfer out of the ICU.
|
This intervention consists of routine ICU nursing care plus an eCASH concept-based analgesia and sedation strategy combined with early goal-directed mobilization.
The eCASH strategy includes early combined intervention, promotion of patient comfort, analgesia-first management, minimization of sedative exposure, and humanistic care.
Early goal-directed mobilization is individualized 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.
其他名称：
|
|
有源比较器：Routine ICU Nursing Care
Participants in this arm will receive routine ICU nursing care, including routine analgesia and sedation management, vital sign monitoring, assessment of consciousness and analgesia/sedation status, muscle strength assessment, airway and tube care, skin care, psychological support, and early activity after clinical stabilization.
|
Routine ICU nursing care includes routine analgesia and sedation management, monitoring of vital signs, assessment of consciousness and analgesia/sedation status, feedback to the attending physician for medication adjustment, muscle strength assessment, regular turning, sputum suction, airway and tube care, skin care, psychological support, and early activity after clinical stabilization.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of ICU-Acquired Weakness
大体时间：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.
|
At transfer out of the ICU
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Dose of Remifentanil
大体时间：From enrollment to transfer out of the ICU, assessed up to 6 months
|
The total amount of remifentanil administered during the ICU intervention period will be recorded and compared between the two groups.
|
From enrollment to transfer out of the ICU, assessed up to 6 months
|
|
Total Dose of Midazolam
大体时间：From enrollment to transfer out of the ICU, assessed up to 6 months
|
The total amount of midazolam administered during the ICU intervention period will be recorded and compared between the two groups.
|
From enrollment to transfer out of the ICU, assessed up to 6 months
|
|
Forced Vital Capacity After Extubation
大体时间：Within 24 hours after extubation
|
Forced vital capacity will be assessed after extubation to evaluate respiratory function recovery.
A higher value indicates better respiratory function.
|
Within 24 hours after extubation
|
|
Peak Expiratory Flow After Extubation
大体时间：Within 24 hours after extubation
|
Peak expiratory flow will be assessed after extubation to evaluate respiratory function recovery.
A higher value indicates better respiratory function.
|
Within 24 hours after extubation
|
|
Duration of Mechanical Ventilation
大体时间：From initiation of mechanical ventilation to successful discontinuation, assessed up to 6 months
|
The duration of mechanical ventilation will be obtained from medical orders and nursing records, calculated from the start to the end of mechanical ventilation.
|
From initiation of mechanical ventilation to successful discontinuation, assessed up to 6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- FAHSU-ECASH-ICUAW-593
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.