Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Clinical Decision Support System for Early Mobilization in the Neuro-ICU (CDSS-EM-ICU)

1 juli 2026 uppdaterad av: National Taiwan University Hospital

Implementation and Feasibility of a Clinical Decision Support System for Early Mobilization in the Intensive Care Unit

This study aims to evaluate the feasibility, safety, and user acceptability of a tablet- and smartphone-based Clinical Decision Support System (CDSS) designed to guide early mobilization for patients with severe neurological conditions in the intensive care unit (ICU). The CDSS standardizes safety screening across neurological, physiological, and device-related domains and provides graded mobility recommendations from Level 0 (passive range of motion) to Level 10 (independent ambulation).

The single-center, single-arm feasibility study will be conducted over six months in neurosurgical and trauma ICUs. Adult patients (≥18 years) with traumatic brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, or acute ischemic stroke will be included. Primary outcomes include protocol adherence, data completeness, and user satisfaction (System Usability Scale). Secondary outcomes include time to first mobilization, maximum mobility level achieved, and adverse event incidence.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

25

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital (NTUH)

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Adults (≥18 years) admitted to the neuro-ICU or trauma ICU.
  • Diagnosis of acute neurological conditions, including traumatic brain injury (TBI), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or acute ischemic stroke (AIS).
  • Hemodynamically stable and deemed eligible for rehabilitation evaluation.
  • Expected ICU stay ≥48 hours.

Exclusion Criteria:

  • Pre-existing severe physical disability (modified Rankin Scale ≥4 before admission).
  • Unstable intracranial pressure or craniectomy with active cerebrospinal fluid leakage.
  • Unstable fractures or contraindications for mobilization as determined by the attending physician.
  • Palliative care status or do-not-resuscitate (DNR) orders.
  • Patients unable to participate in mobilization assessment due to medical instability or family refusal.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: CDSS-Guided Early Mobilization
The CDSS is a tablet- and smartphone-based system designed to standardize safety screening and guide early mobilization decisions for neuro-ICU patients. It provides graded mobility level recommendations based on neurological, physiological, and device-related parameters
Enhet: Clinical Decision Support System (CDSS) for Early Mobilization
The CDSS is a tablet- and smartphone-based system designed to standardize safety screening and guide early mobilization decisions for neuro-ICU patients. It provides graded mobility level recommendations based on neurological, physiological, and device-related parameters.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Protocol Adherence Rate
Tidsram: From ICU admission to ICU discharge (approximately up to 30 days).
The proportion of ICU patient-days in which the mobilization activity executed by the therapist matches the mobility level recommended by the Clinical Decision Support System (CDSS). An adherence rate of ≥80% will be considered acceptable implementation fidelity.
From ICU admission to ICU discharge (approximately up to 30 days).
Data Completeness Rate
Tidsram: Throughout the 6-month study implementation period.
The proportion of required data fields accurately completed within the CDSS interface. A data completeness rate of ≥90% will indicate adequate system usability and workflow compliance.
Throughout the 6-month study implementation period.
User Acceptability (System Usability Scale Score)
Tidsram: Assessed at the end of the 6-month study period.
The mean System Usability Scale (SUS) score obtained from ICU clinicians after using the CDSS for at least 4 weeks. A mean score ≥70 will be considered satisfactory usability. The System Usability Scale (SUS) is a validated 10-item questionnaire with scores ranging from 0 to 100. Higher scores indicate better usability and greater user acceptability. A score of 70 or above is generally considered acceptable usability.
Assessed at the end of the 6-month study period.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to First Mobilization at Level ≥2
Tidsram: From ICU admission until the first mobilization (up to 30 days).
The number of days from ICU admission to the first mobilization episode reaching Level 2 or higher (e.g., edge-of-bed sitting or above) as determined by the CDSS mobility scale.
From ICU admission until the first mobilization (up to 30 days).
Highest Mobility Level Achieved by Day 5
Tidsram: First 5 days after ICU admission.
The maximum mobility level achieved by each participant within the first three ICU days, based on the modified 0-10 ICU Mobility Scale recorded through the CDSS. Modified ICU Mobility Scale (0-10) ranges from 0 to 10, with higher scores indicating greater mobility and functional independence.
First 5 days after ICU admission.
Highest Mobility Level at ICU Discharge
Tidsram: From ICU admission to ICU discharge (approximately up to 30 days).
The highest mobility level reached before ICU discharge, as recorded by the CDSS daily log.
From ICU admission to ICU discharge (approximately up to 30 days).
Incidence of Mobilization-Related Adverse Events
Tidsram: From the first mobilization session until ICU discharge (up to 30 days).
The frequency and type of adverse events occurring during CDSS-guided mobilization, including hemodynamic instability (MAP <65 mmHg or SBP drop >20 mmHg), oxygen desaturation (SpO₂ <90% for >30 seconds), or device dislodgement (unplanned removal of EVD, central line, or ventilator tubing).
From the first mobilization session until ICU discharge (up to 30 days).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Taiwan University Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 september 2025

Primärt slutförande (Faktisk)

22 maj 2026

Avslutad studie (Faktisk)

15 juni 2026

Studieregistreringsdatum

Först inskickad

21 juni 2026

Först inskickad som uppfyllde QC-kriterierna

1 juli 2026

Första postat (Faktisk)

6 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2026

Senast verifierad

1 augusti 2025

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 202507222RINA
  • 115S (Annat bidrag/finansieringsnummer: National Taiwan University Hospital)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera