NCT05281705

Brief 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. 1.Determine the level of mobility that is achieved by each patient on adult ICUs, on a given day in the UK.
  2. 2.Determine the typical physiological profile of patients on ICU that are both able and unable to participate in antigravity exercise
  3. 3.Determine the proportion of adult ICU admissions that achieve out of bed mobilisation in the first 48-72 hours
  4. 4.Explore clinician decision making about mobilisation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

Same day

First QC Date

March 7, 2022

Last Update Submit

March 16, 2022

Conditions

Keywords

PhysiotherapyRehabilitationMobilisation

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients achieving a ICU mobility scale more than 3 on the day of the study

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patient in level 2 \& 3 ICU beds in the UK

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospitals NHS Trust

London, United Kingdom

Location

Related Publications (1)

  • Black C, Sanger H, Battle C, Eden A, Corner E. Feasibility of mobilisation in ICU: a multi-centre point prevalence study of mobility practices in the UK. Crit Care. 2023 Jun 1;27(1):217. doi: 10.1186/s13054-023-04508-4.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

March 3, 2022

Primary Completion

March 3, 2022

Study Completion

March 30, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations