Clinical trial NCT05591950: Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Weakness
Critical Illness
Mechanical Ventilation Complication
Early Mobilization
Keywords: ICU-mobility-scale
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study includes intensive care patients who are treated by the Clinic for Anesthesiology with focus on surgical intensive care medicine at the Charité - Universitätsmedizin Berlin for an expected period of more than 24 hours, who are at least 18 years old and receive ventilation support.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Predictive validity of the IMS
timeFrame: approximate 28 days (till ICU discharge)
Secondary outcomes:
measure: ICU mortality
timeFrame: approximate 28 days (till ICU discharge)
measure: Duration of mechanical ventilation
timeFrame: approximate 28 days (till ICU discharge)
measure: Discharge location
timeFrame: approximate at 28 days (at hospital discharge)
measure: MRC Score
timeFrame: approximate 28 days (till ICU discharge)
measure: Muscle strength
timeFrame: approximate 28 days (till ICU discharge)
measure: 90-day mortality
timeFrame: at 90 days
measure: 90-day function
timeFrame: at 90 days
measure: IMS during the ICU stay
timeFrame: approximate 28 days (till ICU discharge)
measure: ICU-LOS
timeFrame: approximate 28 days (till ICU discharge)
measure: Hospital LOS
timeFrame: approximate 28 days (till discharge)
measure: in-hospital mortality
timeFrame: approximate 28 days (till discharge)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Univiversitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Stefan J Schaller, MD
role: PRINCIPAL_INVESTIGATOR
References: