Mobilising Patients With Severe Brain Injury in Intensive Care

NCT ID: NCT05038930

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-03-16

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.

Conditions

Brain Injury Traumatic Severe; Subarachnoid Hemorrhage; Intracranial Hematoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Intervention protocol

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.

Group Type: EXPERIMENTAL

Mobilisation using the Sara Combilizer

Intervention Type: DEVICE

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

Sedentary protocol

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Arjo, Malmø, Sweden

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Christian Riberholt

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirsten Møller, Professor

Role: STUDY_CHAIR

Department of Neuroanaesthesiology, Rigshospitalet

Locations

Department of Neuroanaesthesiology, Rigshospitalet

Copenhagen, Copenhagen, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 35331944 (View on PubMed)

Other Identifiers

H-21002728

Identifier Type: -

Identifier Source: org_study_id