Clinical trial NCT05038930: Mobilising Patients With Severe Brain Injury in Intensive Care
Official title: Mobilising Patients With Severe Brain Injury in Intensive Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injury Traumatic Severe
Subarachnoid Hemorrhage
Intracranial Hematoma
Keywords: Acquired brain injury
Early mobilisation
Cerebral oxygenation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in partial oxygenation of brain tissue (PbtO2)
timeFrame: 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
Secondary outcomes:
measure: Change in mean arterial pressure (MAP)
timeFrame: 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
measure: Change in heart rate (HR)
timeFrame: 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
measure: Change in intracranial pressure (ICP)
timeFrame: 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
measure: Change in middle cerebral artery flow velocity (MCAv)
timeFrame: 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
measure: Change in microdialysis of cerebrospinal fluid: Glucose level (MDg)
timeFrame: 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
measure: Change in microdialysis of cerebrospinal fluid: Lactate/pyruvate level (MDl/p)
timeFrame: 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
measure: Change in cerebral perfusion pressure (CPP)
timeFrame: 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
measure: Change in mean flow index (Mx)
timeFrame: 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
measure: Change in pressure reactivity index (PRx)
timeFrame: 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
measure: Change in artial arterial carbon dioxide (PaCO2) levels
timeFrame: 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
Other outcomes:
measure: Change in Richmond agitation and sedation scale (RASS)
timeFrame: 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
measure: Change in Glasgow coma scale (GCS)
timeFrame: 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
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neuroanaesthesiology, Rigshospitalet
Study officials:
affiliation: Department of Neuroanaesthesiology, Rigshospitalet
name: Kirsten Møller, Professor
role: STUDY_CHAIR
References:
citation: Riberholt CG, Olsen MH, Berg RMG, Moller K. Mobilising patients with severe acquired brain injury in intensive care (MAWERIC) - Protocol for a randomised cross-over trial. Contemp Clin Trials. 2022 May;116:106738. doi: 10.1016/j.cct.2022.106738. Epub 2022 Mar 21.