Physical Mobilisation to Acquired Brain Injury Patients in Intensive Care Units: a Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Brain Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Describing the Physical Mobilisation Provided to Patients With Acquired Brain Injury in Intensive Care Units: Protocol for a Prospective Cohort Study
Overview
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.
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.
Primary outcome measures
- 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.]
- 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.]
- 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.]
Secondary outcome measures (1)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 2 centers
- Rigshospitalet — Copenhagen
- Odense Universitets Hospital — Odense
Identifiers
NCT: NCT07548580 · H-24084284