Critical Illness, ICU-acquired Weakness, Mechanical Ventilation
Conditions
Keywords
eCASH, Early Goal-Directed Mobilization, Early Mobilization, ICU-Acquired Weakness, Mechanical Ventilation, Intensive Care Unit, Analgesia and Sedation, Minimal Sedation, Critical Care Nursing, Randomized Controlled Trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALeCASH-Based Analgesia and Sedation Strategy Combined With Early Goal-Directed Mobilization
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.
BEHAVIORALRoutine ICU Nursing Care
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.
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Eligible participants 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 concept-based analgesia and sedation strategy combined with early goal-directed mobilization. The control group will receive routine ICU nursing care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ICU-Acquired Weakness | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Dose of Remifentanil | 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. |
| Total Dose of Midazolam | 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. |
| Forced Vital Capacity After Extubation | 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. |
| Peak Expiratory Flow After Extubation | 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. |
| Duration of Mechanical Ventilation | 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. |
Countries
China
Outcome results
None listed