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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Jiangsu
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Suzhou, Jiangsu, Chine, 215006
- The First Affiliated Hospital of Soochow University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Comparateur actif: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of ICU-Acquired Weakness
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Total Dose of Remifentanil
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Processus pathologiques
- Attributs de la maladie
- Manifestations neurocomportementales
- Troubles de la perception
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Maladie critique
- Agnosie
- Thérapeutique
- Soins aux patients
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- En déambulation précoce
Autres numéros d'identification d'étude
- FAHSU-ECASH-ICUAW-593
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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