Critical IllnessNCT05281705
Feasibility@48: Cross Sectional Study of Intensive Care Unit Mobility Practices Across the United Kingdom
An observational study of Critical Illness and Rehabilitation, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Rehabilitation
- How many people
- 750 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2022to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient in level 2 \& 3 ICU beds in the UK
Who may be able to join
- All patients who are admitted to a participating ICU on the study day will be included
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospitals NHS Trust
London
About this study
Official title: Feasibility@ 48: A Cross Sectional Multi-centre Study of Intensive Care Unit (ICU) Mobility Practices Across the United Kingdom.
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:
Read more
- Determine the level of mobility that is achieved by each patient on adult ICUs, on a given day in the UK.
- Determine the typical physiological profile of patients on ICU that are both able and unable to participate in antigravity exercise
- Determine the proportion of adult ICU admissions that achieve out of bed mobilisation in the first 48-72 hours
- 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.
- Conditions
- Critical Illness, Rehabilitation
- Keywords
- Physiotherapy, Rehabilitation, Mobilisation
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving a ICU mobility scale more than 3 on the day of the study
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start3 Mar 2022
- Primary completion3 Mar 2022
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281705
- Sponsor's protocol ID
- EDGE:125652 IRAS:262426
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37264471
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility@ 48: A Cross Sectional Multi-centre Study of Intensive Care Unit (ICU) Mobility Practices Across the United Kingdom.
- ClinicalTrials.gov ID
- NCT05281705
- Acronym / sponsor ID
- EDGE:125652 IRAS:262426
- Conditions
- Critical Illness, Rehabilitation
- Keywords
- Physiotherapy, Rehabilitation, Mobilisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine the level of mobility that is achieved by each patient on adult ICUs, on a given day in the UK.
- Determine the typical physiological profile of patients on ICU that are both able and unable to participate in antigravity exercise
- Determine the proportion of adult ICU admissions that achieve out of bed mobilisation in the first 48-72 hours
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient in level 2 \& 3 ICU beds in the UK
Key inclusion criteria (1 listed)
- All patients who are admitted to a participating ICU on the study day will be included
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients achieving a ICU mobility scale more than 3 on the day of the study
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 37264471Black 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Rehabilitation, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving a ICU mobility scale more than 3 on the day of the study (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05281705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.