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NCT Number: NCT07677488

eCASH and Early Goal-Directed Mobilization to Prevent ICU-Acquired Weakness

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eCASH-Based Analgesia and Sedation Strategy Combined With Early Goal-Directed Mobilization

Behavioral

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.

Other names: eCASH-EGDM, eCASH Plus Early Mobilization, Early Goal-Directed Mobilization

Routine ICU Nursing Care

Behavioral

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.

Other names: Conventional ICU Nursing Care, Usual ICU Care

Primary outcomes

  1. Incidence of ICU-Acquired Weakness

    Time frame: 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 outcomes

  1. Total Dose of Remifentanil

    Time frame: 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.

  2. Total Dose of Midazolam

    Time frame: 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.

  3. Forced Vital Capacity After Extubation

    Time frame: 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.

  4. Peak Expiratory Flow After Extubation

    Time frame: 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.

  5. Duration of Mechanical Ventilation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

Effect of eCASH Concept Combined With Early Goal-Directed Mobilization in Preventing ICU-Acquired Weakness in Mechanically Ventilated ICU Patients: A Randomized Controlled Trial

Acronym: eCASH-EGDM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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