Actively Recruiting
CPAx: Responsiveness and Minimal Clinically Important Difference
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-10-22
120
Participants Needed
3
Research Sites
70 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
M
Monash University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Intensive care unit (ICU) acquired weakness is a common complication associated with long-term physical impairments in survivors of a critical illness. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for physical function and activity in critically ill patients at risk for muscle weakness. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated. This multi-centre, mixed-methods, longitudinal cohort study therefore aims to establish responsiveness and the MCID of the CPAx in the target population from ICU baseline to ICU and hospital discharge. The study uses routine data from standard physiotherapy sessions like mobility, function and activity with no additional burden for critically ill adults. The investigators expect the CPAx to be responsive allowing its use as a primary outcome in future effectiveness trials for the treatment of ICU-acquired weakness using the newly established MCID for sample size calculation. A high quality, rigorously tested measurement tool for physical function and activity in the ICU should benefit researchers, clinicians and patients.
CONDITIONS
Official Title
CPAx: Responsiveness and Minimal Clinically Important Difference
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3e= 18 years
- Mechanical ventilation �3e= 72 hours
- Expected to remain for �3e= 48 hours in the ICU
- Physiotherapy referral
You will not qualify if you...
- Not expected to survive to hospital discharge (imminent to death)
- Second or subsequent ICU admission for this hospital stay
- Transfer from external ICU with an ICU stay of �3e72 hours
- Primary neurological admission diagnosis including stroke, intracerebral haemorrhage, traumatic brain injury
- Known pregnancy
- Living in a care facility before admission due to severe mental or physical disability
- Local regulations refusal of general consent (e.g., Switzerland)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Monash Health
Clayton, Australia
Not Yet Recruiting
2
Alfred Health
Melbourne, Australia
Not Yet Recruiting
3
Inselspital
Bern, Switzerland
Actively Recruiting
Research Team
S
Sabrina Eggmann, PhD
CONTACT
C
Carol Hodgson, Prof
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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