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

NCT07677488 | Completed

• 1 other identifier: FAHSU-ECASH-ICUAW-593
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU-acquired Weakness; Mechanical Ventilation; Critical Illness

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

eCASH Plus Early Goal-Directed Mobilization

EXPERIMENTAL

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

Routine ICU Nursing Care

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: eCASH-EGDM, eCASH Plus Early Mobilization, Early Goal-Directed Mobilization

eCASH Plus 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.

Also known as: Conventional ICU Nursing Care, Usual ICU Care

Routine ICU Nursing Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Critical Illness; Agnosia

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: October 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: May 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)