NCT05591950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

August 17, 2022

Last Update Submit

April 21, 2025

Conditions

Keywords

ICU-mobility-scale

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • ICU mortality

    approximate 28 days (till ICU discharge)

  • Duration of mechanical ventilation

    approximate 28 days (till ICU discharge)

  • Discharge location

    approximate at 28 days (at hospital discharge)

  • MRC Score

    approximate 28 days (till ICU discharge)

  • Muscle strength

    approximate 28 days (till ICU discharge)

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Critically ill adults (age: ≥ 18 years)
  • Expected length of stay in ICU \> 24h
  • Ventilation support

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Univiversitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Muscle WeaknessCritical Illness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsDisease Attributes

Study Officials

  • Stefan J Schaller, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Clinical Director

Study Record Dates

First Submitted

August 17, 2022

First Posted

October 24, 2022

Study Start

January 24, 2023

Primary Completion

November 11, 2024

Study Completion

February 20, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Deidentified data can be requested on reasonable scientific request.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
After publication of scientific manuscript.
Access Criteria
Deidentified data can be requested on reasonable scientific request.

Locations