Physical Mobilisation to Acquired Brain Injury Patients in Intensive Care Units: a Prospective Cohort Study (FOOBScan2)
Describing the Physical Mobilisation Provided to Patients With Acquired Brain Injury in Intensive Care Units: Protocol for a Prospective Cohort Study
Study Overview
Status
Conditions
Detailed Description
In patients with severe acute brain injury (SABI) admitted to neurointensive care units (neuro-ICU), sedation and, consequently, immobilisation are applied to minimize intracranial complications such as increased intracranial pressure and metabolic crisis. However, complications associated to this immobilisation are of major concern. Physical inactivity has been demonstrated to have a negative impact on health in several studies and is accepted as a health threat in the general population.
For patients in neuro-ICUs with severe traumatic brain injury or acute stroke, both inactivity and high levels of inflammatory markers are associated with an increased risk of developing deep vein thrombosis. As an attempt to minimise inactivity-related complications, earlier onset of out-of-bed mobilisation in ICUs has gained increased interest, but the evidence for effect is small and inconclusive and does not address intensity.
The primary objective of this study is to quantify the amount of physical mobilisation provided to patients with moderate to severe acquired brain injury in Scandinavian neuro-ICUs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level mobilisation (as defined under Monitoring physical activity below), and amount of high-level mobilisation during the neuro-ICU stay. As secondary objectives, we aim to explore the association between the frequency of high-level mobilisation sessions during the neuro-ICU stay and the outcomes indicated as relevant by clinicians in Scandinavian neuro-ICUs.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christian Gunge Riberholt, PhD
- Phone Number: 0045-38631600
- Email: christian.gunge.riberholt@regionh.dk
Study Locations
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Copenhagen, Denmark
- Recruiting
- Rigshospitalet
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Contact:
- Christian Gunge Riberholt, PhD
- Phone Number: 0045-38631600
- Email: christian.gunge.riberholt@regionh.dk
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Odense, Denmark
- Active, not recruiting
- Odense Universitets Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (age ≥ 18 years)
- Admitted to a neuro-ICU or to a regular ICU with dedicated beds for severe acquired brain injury patients in Scandinavia
- Patients with moderate to severe traumatic brain injury (TBI) or stroke
- Patients must be intubated and expected to require mechanically ventilation for at least 24 hours.
Exclusion Criteria:
- Patients that are not likely to survive or for whom a decision has been made on palliative care.
- Patients allergic to the Sens monitor patch or showing any type of allergic reactions from the patch after inclusion in the study that needs treatments or results in immediately removal of the patch.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of physical mobilisation
Time Frame: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
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Amount of physical mobilisation provided during stay at neuro-ICU
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From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
|
|
Amount of high-level mobilisation
Time Frame: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
|
Amount of high-level mobilisation during stay at neuro-ICU
|
From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
|
|
Association between intensity and duration of mobilisation
Time Frame: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
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The association between the intensity and duration of mobilisation during stay at neuro-ICU
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From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between frequency of high-level mobilisation and outcomes indicated relevant
Time Frame: From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
|
Outcomes indicated relevant by clinicians in Scandinavian neuro-ICUs
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From admission at the intensive care unit (ICU) until discharge from the ICU, with a maximum of 3 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Gunge Riberholt, PhD, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-24084284
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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