Assessing the CPAx tool for measuring physical function in critically ill patients
Responsiveness and the Minimal Clinically Important Difference of the Chelsea Critical Care Physical Assessment Tool (CPAx) in Critically Ill, Mechanically Ventilated Adults
This study is testing a tool called CPAx to see if it can effectively measure physical function changes in critically ill patients at risk for muscle weakness while they are in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 3 sites (Clayton and 2 other locations) |
| Trial ID | NCT06419699 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the responsiveness and minimal clinically important difference (MCID) of the Chelsea Critical Care Physical Assessment tool (CPAx) in critically ill patients at risk for muscle weakness. By collecting data on mobility, physical function, and activity from mechanically ventilated adults in the ICU, the study will determine how well the CPAx can measure changes over time. The research will utilize routine physiotherapy data without adding extra burden to patients, making it a practical approach to improving care for ICU survivors. The findings are expected to support the CPAx's use as a primary outcome measure in future effectiveness trials.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill adults aged 18 and older who have been mechanically ventilated for at least 72 hours and are expected to remain in the ICU for a minimum of 48 hours.
Not a fit: Patients who are not expected to survive to hospital discharge or those with primary neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated tool to better assess and improve physical function in critically ill patients, potentially enhancing their recovery and quality of life.
How similar studies have performed: Previous studies have confirmed the validity and reliability of the CPAx, but this specific investigation into its responsiveness and MCID is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Mechanical ventilation ≥ 72 hours * Expected to remain for ≥ 48 hours in the ICU * Physiotherapy referral Exclusion Criteria: * 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 \>72 hours) * Primary neurological admission diagnosis (i.e., of the central nervous system including stroke, intracerebral haemorrhage, traumatic brain injury) * Known pregnancy * Living in a care facility pre-admission (severe pre-existing mental or physical disability) * Local regulations (i.e. Switzerland: refusal of general consent)
Where this trial is running
Clayton and 2 other locations
- Monash Health — Clayton, Australia (Not_yet_recruiting)
- Alfred Health — Melbourne, Australia (Not_yet_recruiting)
- Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Sabrina Eggmann, PhD — Inselspital, Bern University Hospital, Switzerland; Monash University, Australia
- Study coordinator: Sabrina Eggmann, PhD
- Email: sabrina.grossenbacher@insel.ch
- Phone: +41 31 632 30 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.