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Mobilising Patients With Severe Brain Injury in Intensive Care (MAWERIC)

Primary Purpose

Brain Injury Traumatic Severe, Subarachnoid Hemorrhage, Intracranial Hematoma

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mobilisation using the Sara Combilizer
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Brain Injury Traumatic Severe focused on measuring Acquired brain injury, Early mobilisation, Cerebral oxygenation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neuroanaesthesiology, RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention protocol

Sedentary protocol

Arm Description

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.

The sedentary protocol will follow the same four phases as the intervention protocol only the patient will remain in the supine position on the Sara Combilizer®. Ideally, no interventions will occur during the 70-minute protocol. If medications are given or other interventions are necessary, this will be registered.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in mean arterial pressure (MAP)
Arterial line
Change in heart rate (HR)
Three-lead electrocardiography
Change in intracranial pressure (ICP)
Electrode placed in the intraparenchymal area
Change in middle cerebral artery flow velocity (MCAv)
Transcranial Doppler sonography using a 2 Megahertz probe.
Change in microdialysis of cerebrospinal fluid: Glucose level (MDg)
Extracellular brain fluids through a small catheter with a semipermeable membrane.
Change in microdialysis of cerebrospinal fluid: Lactate/pyruvate level (MDl/p)
Extracellular brain fluids through a small catheter with a semipermeable membrane.
Change in cerebral perfusion pressure (CPP)
Cerebral perfusion pressure calculated from mean arterial pressure and intracranial pressure
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
Change in pressure reactivity index (PRx)
Correlation between intracranial pressure and arterial blood pressure
Change in artial arterial carbon dioxide (PaCO2) levels
Blood samples drawn from arterial line

Full Information

First Posted
August 23, 2021
Last Updated
March 28, 2023
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05038930
Brief Title
Mobilising Patients With Severe Brain Injury in Intensive Care
Acronym
MAWERIC
Official Title
Mobilising Patients With Severe Brain Injury in Intensive Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
March 16, 2023 (Actual)
Study Completion Date
September 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury Traumatic Severe, Subarachnoid Hemorrhage, Intracranial Hematoma
Keywords
Acquired brain injury, Early mobilisation, Cerebral oxygenation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
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).
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Sedentary protocol
Arm Type
No Intervention
Arm Description
The sedentary protocol will follow the same four phases as the intervention protocol only the patient will remain in the supine position on the Sara Combilizer®. Ideally, no interventions will occur during the 70-minute protocol. If medications are given or other interventions are necessary, this will be registered.
Intervention Type
Device
Intervention Name(s)
Mobilisation using the Sara Combilizer
Other Intervention Name(s)
Arjo, Malmø, Sweden
Intervention Description
The mobilisation with the Sara Combilizer, will be done one time either 24 or 48 hours after stable intracranial pressure
Primary Outcome Measure Information:
Title
Change in partial oxygenation of brain tissue (PbtO2)
Description
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.
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
Secondary Outcome Measure Information:
Title
Change in mean arterial pressure (MAP)
Description
Arterial line
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
Title
Change in heart rate (HR)
Description
Three-lead electrocardiography
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
Title
Change in intracranial pressure (ICP)
Description
Electrode placed in the intraparenchymal area
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
Title
Change in middle cerebral artery flow velocity (MCAv)
Description
Transcranial Doppler sonography using a 2 Megahertz probe.
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
Title
Change in microdialysis of cerebrospinal fluid: Glucose level (MDg)
Description
Extracellular brain fluids through a small catheter with a semipermeable membrane.
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
Title
Change in microdialysis of cerebrospinal fluid: Lactate/pyruvate level (MDl/p)
Description
Extracellular brain fluids through a small catheter with a semipermeable membrane.
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
Title
Change in cerebral perfusion pressure (CPP)
Description
Cerebral perfusion pressure calculated from mean arterial pressure and intracranial pressure
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
Title
Change in mean flow index (Mx)
Description
Pearson's correlation coefficient from mean flow velocity af the middle cerebral artery measured by transcranial Doppler and the cerebral perfusion pressure
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
Title
Change in pressure reactivity index (PRx)
Description
Correlation between intracranial pressure and arterial blood pressure
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
Title
Change in artial arterial carbon dioxide (PaCO2) levels
Description
Blood samples drawn from arterial line
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
Other Pre-specified Outcome Measures:
Title
Change in Richmond agitation and sedation scale (RASS)
Description
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)
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
Title
Change in Glasgow coma scale (GCS)
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian G Riberholt, Ph.D.
Phone
+4522648823
Email
christian.riberholt@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Møller, Professor
Organizational Affiliation
Department of Neuroanaesthesiology, Rigshospitalet
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neuroanaesthesiology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Riberholt, PhD
Phone
22648823
Email
christian.riberholt@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared by reasonable request from other researcher. Due to the small number of included patients this will be done in an anonymised way, so that recognising individual patients are not possible.
IPD Sharing Time Frame
Data will be available from december 2022.
IPD Sharing Access Criteria
All requests will be reviewed by the primary investigator and the sponsor.
Citations:
PubMed Identifier
35331944
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.
Results Reference
derived

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Mobilising Patients With Severe Brain Injury in Intensive Care

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