Clinical trial NCT06419699: CPAx: Responsiveness and Minimal Clinically Important Difference
Official title: Responsiveness and the Minimal Clinically Important Difference of the Chelsea Critical Care Physical Assessment Tool (CPAx) in Critically Ill, Mechanically Ventilated Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Muscle Weakness
Critical Illness Myopathy
Critical Illness Polyneuropathy
Critical Illness Polyneuromyopathy
Physical Inactivity
Keywords: Physiotherapy
Physical function and activity
Early rehabilitation
Measurement instrument
Critical illness
Critical care outcomes
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Monash University
First posted: 2024-05-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population are critically ill adults who are mechanically ventilated for a prolonged period (≥ 72 hours) and who have an increased risk for ICUAW and long-term impairment.

Brief summary: 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.

Detailed description: The use of invasive life support in critically ill patients clearly saves lives but carries substantial risks, including intensive care unit (ICU) acquired weakness and long-term disability. The investigators urgently need a valid, reliable, and responsive measurement tool for this population to use in clinical practice and trials. The Chelsea Critical Care Physical Assessment tool (CPAx) is a promising measurement instrument to measure change in critically ill patients' physical function and activity. After several studies have confirmed its validity and excellent reliability, it is time to confirm responsiveness and to establish the MCID in a large, international sample of the target population. This multi-centre, mixed-methods, longitudinal cohort study will include critically ill, mechanically ventilated (\>72h) adults at risk for muscle weakness and collect their mobility, physical function and activity with the CPAx and other relevant measures at ICU baseline, to ICU and hospital discharge. Responsiveness will be determined by the ability of the CPAx to identify change according to a prespecified anchor (criterion validity) and by testing prospective hypotheses about the expected magnitude of change between the CPAx and other relevant measures (construct validity). The MCID will be established with anchor- and distribution-based methods, whereby a seven-point global rating of change scale obtained from treating ICU physiotherapists will serve as anchor to distinguish improved from unchanged patients.

Eligibility 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)

Primary outcomes:
measure: Chelsea Critical Care Physical Assessment tool (CPAx) change score
timeFrame: Assessed at ICU discharge (within 24 hours before or after ICU discharge)
Secondary outcomes:
measure: CPAx change score
timeFrame: Assessed at hospital discharge (last value before discharge)
measure: Global rating of change scale
timeFrame: ICU and hospital discharge (change for ICU and hospital period)
measure: ICU Mobility Scale
timeFrame: ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
measure: Medical Research Council Sum Score
timeFrame: ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
measure: Richmond Agitation-Sedation Scale
timeFrame: ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
measure: Modified Iowa Level of Assistance Scale
timeFrame: ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge
measure: ICU and discharge destinations
timeFrame: ICU and hospital discharge
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash Health
city: Melbourne
country: Australia
facility: Alfred Health
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Inselspital, Bern University Hospital, Switzerland; Monash University, Australia
name: Sabrina Eggmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30.
citation: Eggmann S, Verra ML, Stefanicki V, Kindler A, Seyler D, Hilfiker R, Schefold JC, Bastiaenen CHG, Zante B. German version of the Chelsea Critical Care Physical Assessment Tool (CPAx-GE): translation, cross-cultural adaptation, validity, and reliability. Disabil Rehabil. 2022 Aug;44(16):4509-4518. doi: 10.1080/09638288.2021.1909152. Epub 2021 Apr 19.
citation: Eggmann S, Verra ML, Stefanicki V, Kindler A, Schefold JC, Zante B, Bastiaenen CHG. Predictive validity of the Chelsea Critical Care Physical Assessment tool (CPAx) in critically ill, mechanically ventilated adults: a prospective clinimetric study. Disabil Rehabil. 2023 Jan;45(1):111-116. doi: 10.1080/09638288.2021.2022785. Epub 2022 Jan 7.