Actively Recruiting

Age: 18Years +
All Genders
NCT06419699

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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