Mobilising Patients With Severe Brain Injury in Intensive Care
- Conditions
- Subarachnoid HemorrhageIntracranial HematomaBrain Injury Traumatic Severe
- Interventions
- Device: Mobilisation using the Sara Combilizer
- Registration Number
- NCT05038930
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 22
- 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
- Unstable spinal cord injury
- Unstable injury in the lower extremities prohibiting mobilisation
- No consent from nearest relative
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention protocol Mobilisation using the Sara Combilizer Phase 1. The patient will be positioned in a supine position for 20 minutes on the Sara Combilizer®. When necessary, the head of the patient can be elevated to a maximum of 30 degrees during the 20 minutes baseline measurements. Phase 2. The patient will be positioned in a seated position for 10 minutes with the trunk and head elevated to at least 70 degrees. Phase 3. The patient will be moved to the standing position for 20 minutes with an elevation angle of the Sara Combilizer of at least 70 degrees. If patients become haemodynamically unstable during the seated or standing position, they will be returned to the supine position, and the intervention will be terminated. Phase 4. The patient is returned to the phase 1 position (supine). Further measurements are made for at least 20 minutes.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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: 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 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 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
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
Trial Locations
- Locations (1)
Department of Neuroanaesthesiology, Rigshospitalet
🇩🇰Copenhagen, Denmark