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TAVIMS: Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT05591950
Collaborator
(none)
100
Enrollment
1
Location
11.2
Anticipated Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Intensive care unit acquired weakness (ICUAW) is a common issue in critically ill patients. Early mobilization can reduce the occurrence of ICUAW. This requires a standardized procedure based on validated scales. One such scale is Carol Hodgson's ICU Mobility Scale (IMS).

The subject of the study is the translation of the IMS into German and the validation of its reliability and predictive power with regard to various clinical outcomes. Furthermore we want to investigate the communication about the mobilisation status of ICU-patients between the different medical disciplines that are involved in patient care.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Übersetzung Und Validierung Einer Deutschen Version Der Intensive Care Unit Mobility Scale (IMS) Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)
    Actual Study Start Date :
    Jan 24, 2023
    Anticipated Primary Completion Date :
    Nov 30, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Predictive validity of the IMS [approximate 28 days (till ICU discharge)]

      Predictive validity of the IMS-score performed in the first 24 hours after admission to the ICU for the length of stay in the ICU

    Secondary Outcome Measures

    1. ICU mortality [approximate 28 days (till ICU discharge)]

      Mortality during ICU stay

    2. Duration of mechanical ventilation [approximate 28 days (till ICU discharge)]

      Duration of invasive mechanical ventilator dependency

    3. Discharge location [approximate at 28 days (at hospital discharge)]

      If the patient was discharged home or to another facility at hospital discharge

    4. MRC Score [approximate 28 days (till ICU discharge)]

      Muscle strength at ICU discharge measured using the Medical Research Council score

    5. Muscle strength [approximate 28 days (till ICU discharge)]

      Muscle strength at ICU discharge measured using hand grip strength

    6. 90-day mortality [at 90 days]

      Mortality at 90 days

    7. 90-day function [at 90 days]

      Physical function of the patient at 90 days

    8. IMS during the ICU stay [approximate 28 days (till ICU discharge)]

      achieved mobilization level during the ICU stay using the ICU Mobility Scale (IMS)

    9. ICU-LOS [approximate 28 days (till ICU discharge)]

      Length of stay in the ICU

    10. Hospital LOS [approximate 28 days (till discharge)]

      Length of stay in the hospital

    11. in-hospital mortality [approximate 28 days (till discharge)]

      Mortality during the Hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Critically ill adults (age: ≥ 18 years)

    • Expected length of stay in ICU > 24h

    • Ventilation support

    Exclusion Criteria:

    • Patients transferred from other ICUs

    • Patients with pre-existing functional limitations

    • Patients with functional limitations due to the admission diagnosis (e.g. stroke. with hemiparesis)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité - Univiversitätsmedizin Berlin Berlin Germany 10117

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Principal Investigator: Stefan J Schaller, MD, Charite University, Berlin, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefan J Schaller, Deputy Clinical Director, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT05591950
    Other Study ID Numbers:
    • TAVIMS
    First Posted:
    Oct 24, 2022
    Last Update Posted:
    Jan 31, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stefan J Schaller, Deputy Clinical Director, Charite University, Berlin, Germany
    ICU-mobility-scale
    Additional relevant MeSH terms:
    Muscle Weakness
    Critical Illness

    Study Results

    No Results Posted as of Jan 31, 2023