Physical Function in Critical Care (PaciFIC)

Intensive Care (ICU) Myopathy Clinical Trial

— PaciFIC  

Official title:

Physical Function in Critical Care (PaciFIC): An Multi-centre Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911896
• Other study ID #: 2015026
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: October 26, 2017
• Start date: August 2015
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Impairment in physical function is a significant problem for survivors of critical illness. There is a growing urgency to develop a core set of outcome measures, which can be adopted in clinical and research practice to evaluate efficacy in response to interventions such as rehabilitation.

Phase 1: Development of a new outcome measure. This study aims to examine the development of a single outcome measure which may be able to be utilised across the continuum of recovery of critical illness in the evaluation of physical function. The study will involve examination of two common physical function measures - the Physical Function in intensive care test scored (PFIT-s) and De Morton Mobility Index (DEMMI) and the development of a new measure based on rasch principles which may be able to capture physical functioning changes in individuals with critical illness. Aims: (1) To determine the clinical utility of two physical function measures (DEMMI and PFIT-s) when used in isolation across the hospital admission; and (2) To transform the (15-item) DEMMI and (4-item) PFIT-s into a single measure to evaluate function in intensive care survivors using Rasch analytical principles.

Phase 2: Measurement properties of the PACIFIC physical function outcome measure in an independent validation sample.

Description:

Consecutive eligible patients will be recruited into the study.

Phase 1: Two outcome measures - PFIT-s and DEMMI will be performed within 24 hour period. Order of testing will be randomised to minimise testing bias. Time-points of assessment are: awakening, ICU discharge and hospital discharge. Weekly measures will also be performed if required in ICU and/or ward settings for up to a maximum of 30 days in each setting. The measurement properties of the individual tools PFIT-s and DEMMI will be examined (e.g. validity, responsiveness).

Phase 2: Based on the findings in Phase 1 a new single outcome measure will be developed. In the second phase examination of the measurement properties of the tool will be undertaken including (reliability, validity, responsiveness).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults > 18 years of age

• Mechanically ventilated > 48 hours

• Premorbid able to ambulate at least 10m independently prior to ICU admission (+/- gait aid)

Exclusion Criteria:

• Premorbid physical or cognitive impairment which would prevent ability to perform functional measures

• New neurological impairment such as stroke or spinal cord injury

• Trauma or orthopaedic injury requiring period of immobilization or non weight bearing status

• Traumatic brain injury with focal neurology

Related Conditions & MeSH terms

• Intensive Care (ICU) Myopathy

Locations

Country	Name	City	State
Australia	University of South Australia and Flinders Medical Centre	Adelaide	South Australia
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Brazil	Escola superior de ciências da saúde ESCS	Brazil
Singapore	National University Hospital	Singapore

Sponsors (5)

Lead Sponsor	Collaborator
University of Melbourne	Escola Superior da Saude, Brazil, Flinders Medical Centre, Melbourne Health, National University Hospital, Singapore

Countries where clinical trial is conducted

Australia,  Brazil,  Singapore, 

References & Publications (2)

Parry SM, Denehy L, Beach LJ, Berney S, Williamson HC, Granger CL. Functional outcomes in ICU – what should we be using? – an observational study. Crit Care. 2015 Mar 29;19:127. doi: 10.1186/s13054-015-0829-5. — View Citation

Parry SM, Granger CL, Berney S, Jones J, Beach L, El-Ansary D, Koopman R, Denehy L. Assessment of impairment and activity limitations in the critically ill: a systematic review of measurement instruments and their clinimetric properties. Intensive Care Me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Function in Intensive Care Test scored (PFIT-s) and De Morton Mobility Index from ICU awakening to hospital discharge	Both measures are primary - there will be a single measure developed as composite in line with aims of this observational study	Baseline to hospital discharge (up to 3 months)