Brain Injury Traumatic Severe, Intracranial Hematoma, Subarachnoid Hemorrhage
Conditions
Keywords
Acquired brain injury, Early mobilisation, Cerebral oxygenation
Brief summary
Introduction Patients with severe brain injury are often restricted to bed rest during the early period of brain injury which may lead to unwanted secondary complications. There is lack of evidence of when to initiate the first mobilisation. The Sara Combilizer® is an easy and efficient tool for mobilising patients with severe injuries, including brain injury. Through a randomised cross-over trial the investigators will investigate the impact of early mobilisation on patients with severe acquired brain injury caused by traumatic brain injury, subarachnoid brain injury or intracranial haematoma. The investigators hypothesise that mobilisation using the Sara Combilizer® does not affect partial oxygenation of brain tissue.
Detailed description
The primary purpose of this study is to quantify cerebral oxygenation, when mobilising patients with severe brain injury using a Sara Combilizer® to the seated position and during passive standing. This study is conducted at the Department of Neurointensive care and Neuroanaesthesiology, Rigshospitalet, Copenhagen. Based on the International Conference on harmonisation-Good Clinical Practice guidelines and the Danish Good Clinical Practice administrative order, a table regarding the responsibilities of sponsor/investigators before, during and after the clinical trial, will be filled and signed in order to avoid misunderstandings. This table can be found in the Trial Master File (TMF) located at the primary investigator's office and the sponsor's office. This study is designed as a cross-over study with patients randomly assigned to (1) an initial intervention protocol on the first day and with a passive sedentary protocol on the second, or (2) an initial passive sedentary protocol on the first day followed by an intervention protocol on the second day. Randomisation Included patients will, after stabilisation of ICP, be randomised to start with either the intervention or sedentary protocol, with the opposite protocol on the second day. A computer-generated randomisation algorithm will be created in REDCap, with age and Glasgow Coma Score (GCS) as dichotomised stratification variables. Age will be divided into young (18 to 60 years) and old (61+ years), and the GCS into severe brain injury (GCS 3-8) and moderate to mild injury (GCS 9-15). The following four composite groups of age and GCS will ensure an equal distribution of the patients within each stratum.
Interventions
DEVICEMobilisation using the Sara Combilizer
The mobilisation with the Sara Combilizer, will be done one time either 24 or 48 hours after stable intracranial pressure
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Masking description
All analysis will be done by a statistician blinded to the intervention or sedentary protocol. Stored data will be named according to patient ID, assigned a letter according to the protocol and a number according to the measurement phase (e.g. ID1011A2).
Intervention model description
This study is designed as a cross-over study with patients randomly assigned to (1) an initial intervention protocol on the first day and with a passive sedentary protocol on the second, or (2) an initial passive sedentary protocol on the first day followed by an intervention protocol on the second day.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Traumatic brain injury, subarachnoid haemorrhage, intracranial haematoma * Sedated for at least 48 hours after admission * Equipment measuring partial brain tissue oxygenation and intracranial pressure * Understands spoken and written Danish
Exclusion criteria
* Unstable spinal cord injury * Unstable injury in the lower extremities prohibiting mobilisation * No consent from nearest relative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in partial oxygenation of brain tissue (PbtO2) | Head-up tilt PbtO2 (delta between supine and standing values) compared to sedentary PbtO2 (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | PbtO2 measures the partial pressure of oxygen in the extra-cellular fluid of the brain continuously. Therefore, this value represents the balance between oxygen delivered and consumed and reflects the perfusion of the capillaries in the area of interest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean arterial pressure (MAP) | Head-up tilt MAP (delta between supine and standing values) compared to sedentary MAP (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Arterial line |
| Change in heart rate (HR) | Head-up tilt HR (delta between supine and standing values) compared to sedentary HR (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Three-lead electrocardiography |
| Change in intracranial pressure (ICP) | Head-up tilt ICP (delta between supine and standing values) compared to sedentary ICP (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Electrode placed in the intraparenchymal area |
| Change in middle cerebral artery flow velocity (MCAv) | Head-up tilt MCAv (delta between supine and standing values) compared to sedentary MCAv (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Transcranial Doppler sonography using a 2 Megahertz probe. |
| Change in microdialysis of cerebrospinal fluid: Glucose level (MDg) | Intervention protocol MDg (delta between supine and standing values) compared to sedentary MDg (calculated by subtracting baseline from after protocol values) measured continuously after 24 and 48 hours from stable intracranial pressure | Extracellular brain fluids through a small catheter with a semipermeable membrane. |
| Change in pressure reactivity index (PRx) | Head-up tilt PRx (delta between supine and standing values) compared to sedentary PRx (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Correlation between intracranial pressure and arterial blood pressure |
| Change in artial arterial carbon dioxide (PaCO2) levels | Head-up tilt PaCO2 (delta between supine and standing values) compared to sedentary PaCO2 (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Blood samples drawn from arterial line |
| Change in microdialysis of cerebrospinal fluid: Lactate/pyruvate level (MDl/p) | Intervention protocol MDl/p (delta between supine and standing values) compared to sedentary MDl/p (calculated by subtracting baseline from after protocol values) measured continuously after 24 and 48 hours from stable intracranial pressure | Extracellular brain fluids through a small catheter with a semipermeable membrane. |
| Change in cerebral perfusion pressure (CPP) | Head-up tilt CPP (delta between supine and standing values) compared to sedentary CPP (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Cerebral perfusion pressure calculated from mean arterial pressure and intracranial pressure |
| Change in mean flow index (Mx) | Head-up tilt Mx (delta between supine and standing values) compared to sedentary Mx (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Pearson's correlation coefficient from mean flow velocity af the middle cerebral artery measured by transcranial Doppler and the cerebral perfusion pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Richmond agitation and sedation scale (RASS) | Head-up tilt RASS (delta between supine and standing values) compared to sedentary RASS (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Observational scale to determine the level of sedation and arousal of the patient. Lowest score (-5) is equivalent to coma (deeply sedated) and highest score (4) is equivalent to aggressive (agitated state). A score of 0 is awake and calm (desireable score) |
| Change in Glasgow coma scale (GCS) | Head-up tilt GCS (delta between supine and standing values) compared to sedentary GCS (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure | Observational scale used to determine the level of arousal in patients with brain injury. The score ranges from 3 (lowest score) equivalent to coma and 15 (highest score) equivalent to normal level of arousal. Three subscores comprises the total score eye response (1-4), verbal response (1-5) and motor response (1-6). A higher score is better |
Countries
Denmark
Outcome results
None listed