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Completed

NCT Number: NCT05038930

Mobilising Patients With Severe Brain Injury in Intensive Care

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.

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Key information

Conditions

Brain Injury Traumatic Severe Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracranial Hematoma Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neuroanaesthesiology, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobilisation using the Sara Combilizer

Device

The mobilisation with the Sara Combilizer, will be done one time either 24 or 48 hours after stable intracranial pressure

Other names: Arjo, Malmø, Sweden

Primary outcomes

  1. Change in partial oxygenation of brain tissue (PbtO2)

    Time frame: 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 outcomes

  1. Change in mean arterial pressure (MAP)

    Time frame: 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

  2. Change in heart rate (HR)

    Time frame: 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

  3. Change in intracranial pressure (ICP)

    Time frame: 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

  4. Change in middle cerebral artery flow velocity (MCAv)

    Time frame: 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.

  5. Change in microdialysis of cerebrospinal fluid: Glucose level (MDg)

    Time frame: 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.

  6. Change in microdialysis of cerebrospinal fluid: Lactate/pyruvate level (MDl/p)

    Time frame: 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.

  7. Change in cerebral perfusion pressure (CPP)

    Time frame: 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

  8. Change in mean flow index (Mx)

    Time frame: 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

  9. Change in pressure reactivity index (PRx)

    Time frame: 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

  10. Change in artial arterial carbon dioxide (PaCO2) levels

    Time frame: 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

Other outcomes

  1. Change in Richmond agitation and sedation scale (RASS)

    Time frame: 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)

  2. Change in Glasgow coma scale (GCS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: MAWERIC

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2021
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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