Feasibility@48: Cross Sectional Study of Intensive Care Unit Mobility Practices Across the United Kingdom

Critical Illness Clinical Trial

Official title:

Feasibility@ 48: A Cross Sectional Multi-centre Study of Intensive Care Unit (ICU) Mobility Practices Across the United Kingdom.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05281705
• Other study ID #: EDGE:125652 IRAS:262426
• Status: Active, not recruiting
• Start date: March 3, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2022
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Intensive Care Unit (ICU) patients commonly experience muscle loss at a rate of 2-3% day. Traditionally, critically ill patients have been managed in bed, however current research suggests that prolonged bedrest cause mechanical silencing of the muscles and exacerbates this muscle wasting. This ICU acquired weakness (ICUAW) leads to poor functional outcome and higher mortality. Research suggests that early out-of-bed mobilisation should occur within 48-hours of ICU admission to militate against this risk, however, this is only achieved in 30% of cases. Common barriers to mobilisation are unstable blood pressure, ventilation, sedation and fatigue. It is plausible that 48-hours is an unrealistic timeframe for mobilisation.

The aim of this study is to explore the mobility practices on a given day in UK adult ICUs. The objectives are to:

1. Determine the level of mobility that is achieved by each patient on adult ICUs, on a given day in the UK.

2. Determine the typical physiological profile of patients on ICU that are both able and unable to participate in antigravity exercise

3. Determine the proportion of adult ICU admissions that achieve out of bed mobilisation in the first 48-72 hours

4. Explore clinician decision making about mobilisation

This is a multi-centre cross-sectional study on one-day only. Over a 24-hour period data will be collected for all ICU patients at the participating centres. The lead physiotherapist will record the highest level of mobility achieved that day, and the physiological parameters from clinical observations. The reasons for the level of mobility achieved will be ranked in order of importance. These data are routinely collected. Data will be anonymised.

Data will be analysed to determine feasibility of mobilisation at 48hours and develop a flow diagram of mobilisation decision-making.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: March 30, 2023
• Est. primary completion date: March 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients who are admitted to a participating ICU on the study day will be included

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Critical Illness
• Rehabilitation

Locations

Country	Name	City	State
United Kingdom	University College London Hospitals NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients achieving a ICU mobility scale more than 3 on the day of the study		Day 1