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
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Jiangsu
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Suzhou, Jiangsu, Cina, 215006
- The First Affiliated Hospital of Soochow University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
Altri nomi:
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Comparatore attivo: 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.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of ICU-Acquired Weakness
Lasso di tempo: At transfer out of the ICU
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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.
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At transfer out of the ICU
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Dose of Remifentanil
Lasso di tempo: From enrollment to transfer out of the ICU, assessed up to 6 months
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The total amount of remifentanil administered during the ICU intervention period will be recorded and compared between the two groups.
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From enrollment to transfer out of the ICU, assessed up to 6 months
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Total Dose of Midazolam
Lasso di tempo: From enrollment to transfer out of the ICU, assessed up to 6 months
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The total amount of midazolam administered during the ICU intervention period will be recorded and compared between the two groups.
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From enrollment to transfer out of the ICU, assessed up to 6 months
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Forced Vital Capacity After Extubation
Lasso di tempo: Within 24 hours after extubation
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Forced vital capacity will be assessed after extubation to evaluate respiratory function recovery.
A higher value indicates better respiratory function.
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Within 24 hours after extubation
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Peak Expiratory Flow After Extubation
Lasso di tempo: Within 24 hours after extubation
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Peak expiratory flow will be assessed after extubation to evaluate respiratory function recovery.
A higher value indicates better respiratory function.
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Within 24 hours after extubation
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Duration of Mechanical Ventilation
Lasso di tempo: From initiation of mechanical ventilation to successful discontinuation, assessed up to 6 months
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The duration of mechanical ventilation will be obtained from medical orders and nursing records, calculated from the start to the end of mechanical ventilation.
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From initiation of mechanical ventilation to successful discontinuation, assessed up to 6 months
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Processi patologici
- Attributi della malattia
- Manifestazioni neurocomportamentali
- Disturbi percettivi
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Malattia critica
- Agnosi
- Terapie
- Cura del paziente
- Riabilitazione
- Assistenza post -terapia
- Continuità della cura del paziente
- Ambulazione precoce
Altri numeri di identificazione dello studio
- FAHSU-ECASH-ICUAW-593
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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