Mobilising Patients With Severe Brain Injury in Intensive Care

NCT05038930 | Completed

• 1 other identifier: H-21002728
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury Traumatic Severe; Subarachnoid Hemorrhage; Intracranial Hematoma

Keywords

Acquired brain injury; Early mobilisation; Cerebral oxygenation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (2)

• Change in Richmond agitation and sedation scale (RASS)

  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

• Change in Glasgow coma scale (GCS)

  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

Study Arms (2)

Intervention protocol

EXPERIMENTAL

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.

Device: Mobilisation using the Sara Combilizer

Sedentary protocol

NO INTERVENTION

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.

Interventions

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

Also known as: Arjo, Malmø, Sweden

Intervention protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable spinal cord injury
• Unstable injury in the lower extremities prohibiting mobilisation
• No consent from nearest relative

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Neuroanaesthesiology, Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 35331944 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Brain Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Kirsten Møller, Professor

  Department of Neuroanaesthesiology, Rigshospitalet

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 9, 2021
• Study Start: October 1, 2021
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available from december 2022.
• Access Criteria: All requests will be reviewed by the primary investigator and the sponsor.

Locations

DK (1)