Mobilising Patients With Severe Brain Injury in Intensive Care

Subarachnoid Hemorrhage Clinical Trial

— MAWERIC  

Official title:

Mobilising Patients With Severe Brain Injury in Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05038930
• Other study ID #: H-21002728
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 16, 2023

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: Christian G Riberholt, Ph.D.
• Phone: +4522648823
• Email: christian.riberholt[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: September 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Severe
• Hematoma
• Hemorrhage
• Intracranial Hematoma
• Subarachnoid Hemorrhage
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Neuroanaesthesiology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Richmond agitation and sedation scale (RASS)	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)	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
Other	Change in Glasgow coma scale (GCS)	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	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
Primary	Change in partial oxygenation of brain tissue (PbtO2)	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.	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	Change in mean arterial pressure (MAP)	Arterial line	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
Secondary	Change in heart rate (HR)	Three-lead electrocardiography	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
Secondary	Change in intracranial pressure (ICP)	Electrode placed in the intraparenchymal area	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
Secondary	Change in middle cerebral artery flow velocity (MCAv)	Transcranial Doppler sonography using a 2 Megahertz probe.	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
Secondary	Change in microdialysis of cerebrospinal fluid: Glucose level (MDg)	Extracellular brain fluids through a small catheter with a semipermeable membrane.	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
Secondary	Change in microdialysis of cerebrospinal fluid: Lactate/pyruvate level (MDl/p)	Extracellular brain fluids through a small catheter with a semipermeable membrane.	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
Secondary	Change in cerebral perfusion pressure (CPP)	Cerebral perfusion pressure calculated from mean arterial pressure and intracranial pressure	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
Secondary	Change in mean flow index (Mx)	Pearson's correlation coefficient from mean flow velocity af the middle cerebral artery measured by transcranial Doppler and the cerebral perfusion pressure	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
Secondary	Change in pressure reactivity index (PRx)	Correlation between intracranial pressure and arterial blood pressure	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
Secondary	Change in artial arterial carbon dioxide (PaCO2) levels	Blood samples drawn from arterial line	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