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

28. Juni 2026 aktualisiert von: Qianru Lin, The First Affiliated Hospital of Soochow University

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

70

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Andere Namen:
  • eCASH-EGDM
  • eCASH Plus Early Mobilization
  • Early Goal-Directed Mobilization
Aktiver Komparator: 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.
Verhalten: 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.
Andere Namen:
  • Conventional ICU Nursing Care
  • Usual ICU Care

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of ICU-Acquired Weakness
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total Dose of Remifentanil
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The First Affiliated Hospital of Soochow University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Oktober 2025

Primärer Abschluss (Tatsächlich)

30. April 2026

Studienabschluss (Tatsächlich)

1. Mai 2026

Studienanmeldedaten

Zuerst eingereicht

23. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FAHSU-ECASH-ICUAW-593

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared due to patient privacy, ethical restrictions, and institutional data management requirements.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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