Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419699
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
CPAx Responsiveness and Minimal Clinically Important Difference
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Responsiveness and the Minimal Clinically Important Difference of the Chelsea Critical Care Physical Assessment Tool CPAx in Critically Ill Mechanically Ventilated Adults
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None