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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Mechanical Ventilation; ICU-acquired Weakness
• Intervention / Treatment: Behavioral: eCASH-Based Analgesia and Sedation Strategy Combined With Early Goal-Directed Mobilization; Behavioral: Routine ICU Nursing Care

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: eCASH-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.; Other Names: eCASH-EGDM; eCASH Plus Early Mobilization; Early Goal-Directed Mobilization
Active Comparator: 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.	Behavioral: Routine 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.; Other Names: Conventional ICU Nursing Care; Usual ICU Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ICU-Acquired Weakness	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Dose of Remifentanil	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	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	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	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	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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): May 1, 2026

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Randomized Controlled Trial; Mechanical Ventilation; Critical Care Nursing; Early Mobilization; Minimal Sedation; eCASH; Early Goal-Directed Mobilization; ICU-Acquired Weakness; Analgesia and Sedation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Disease Attributes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Critical Illness; Agnosia; Therapeutics; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Early Ambulation
• Other Study ID Numbers: FAHSU-ECASH-ICUAW-593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to patient privacy, ethical restrictions, and institutional data management requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No