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

Critical Illness Clinical Trial

— TAVIMS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591950
• Other study ID #: TAVIMS
• Status: Recruiting
• Start date: January 24, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Charite University, Berlin, Germany
• Contact: Stefan J Schaller, MD
• Phone: +49 30 450 531 052
• Email: stefan.schaller[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Early Mobilization
• Mechanical Ventilation Complication
• Muscle Weakness

Locations

Country	Name	City	State
Germany	Charité - Univiversitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive validity of the IMS	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	approximate 28 days (till ICU discharge)
Secondary	ICU mortality	Mortality during ICU stay	approximate 28 days (till ICU discharge)
Secondary	Duration of mechanical ventilation	Duration of invasive mechanical ventilator dependency	approximate 28 days (till ICU discharge)
Secondary	Discharge location	If the patient was discharged home or to another facility at hospital discharge	approximate at 28 days (at hospital discharge)
Secondary	MRC Score	Muscle strength at ICU discharge measured using the Medical Research Council score	approximate 28 days (till ICU discharge)
Secondary	Muscle strength	Muscle strength at ICU discharge measured using hand grip strength	approximate 28 days (till ICU discharge)
Secondary	90-day mortality	Mortality at 90 days	at 90 days
Secondary	90-day function	Physical function of the patient at 90 days	at 90 days
Secondary	IMS during the ICU stay	achieved mobilization level during the ICU stay using the ICU Mobility Scale (IMS)	approximate 28 days (till ICU discharge)
Secondary	ICU-LOS	Length of stay in the ICU	approximate 28 days (till ICU discharge)
Secondary	Hospital LOS	Length of stay in the hospital	approximate 28 days (till discharge)
Secondary	in-hospital mortality	Mortality during the Hospital stay	approximate 28 days (till discharge)