Describing the Physical Mobilisation Provided to Patients With Acquired Brain Injury in Intensive Care Units: Protocol for a Prospective Cohort Study
| Registry | NCT07548580, acronym FOOBScan2 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 198 (Estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet (Other) |
| Conditions | Acute Brain Injury |
| Dates | start 2025-08-25, primary completion 2026-06-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-04-23, last updated 2026-04-23 |
| Locations | 2 sites in Denmark |
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All trials for Acute Brain Injury
The 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-ICs, and the association between intensity and duration of mobilisation, physiological data perceived to be related to the safety of high-level mobilisation, and amount of high-level mobilisation during the neuro-ICU stay.
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.
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark | Recruiting |
| Odense Universitets Hospital | Odense | Denmark | Active not recruiting |