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

1. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Protocol Adherence Rate
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Mobilization at Level ≥2
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Taiwan University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. september 2025

Primær færdiggørelse (Faktiske)

22. maj 2026

Studieafslutning (Faktiske)

15. juni 2026

Datoer for studieregistrering

Først indsendt

21. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. august 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202507222RINA
  • 115S (Andet bevillings-/finansieringsnummer: National Taiwan University Hospital)

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Kliniske forsøg med Clinical Decision Support System (CDSS) for Early Mobilization

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