Sympathetic effects of early mobilization in patients with severe brain injuries

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Participants are randomized into 3 groups with different protocols of mobilization. Group 1: Participants are mobilized out of bed by physiotherapists, according to usual clinical physiotherapy standard recommendations in the hospital. Group 2: Participants are mobilized out of bed by physiotherapists for the first time after having received a session of MOTOmed‐letto®. MOTOmed Letto® is an automatic system for leg mobilization in a supine position, miming a bicycle. Patients are mobilized in bed by either physiotherapists and with a MOTOmed® session of almost 30 minutes 5 days/week. Then, after a minimum of 7 days, patients are mobilized out of bed by physiotherapists for the first time after a MOTOmed® session. Group 3: Participants are mobilized out of bed by physiotherapists for the first time following the Erigo® protocol. Erigo® is a tilting table with an integrated leg movement system, which allows progressive verticalization of the patient, adjustable to patient needs and possibilities. During the first step (5 minutes) the patient lies in a supine position, with their head at 0°, and the Erigo® started leg movements. During the second step (30 min) the patient is progressively verticalized (at 30°‐50°‐70° for 10 minutes each) while the Erigo® continues to move the patient's legs. During the third step (10 minutes) the patient is returned to a supine position. Participants in all groups have their blood pressure, heart rate and respiratory rate measured at T1 (admission to the Intermediate Care Unit), T2 (the moment directly before the first mobilization out of bed), T3 (during the first mobilization out of bed) and T4 (one hour after lying in bed again). Participants also have a blood sample taken at T2, T3 and T4 to measure catecholamine and metanephrine concentrations, and those patients who have has a subarachnoid hemorrhage also have a transcranial Doppler at T1, T2 and T4. CONDITION: Brain injury ; Nervous System Diseases ; Brain injury PRIMARY OUTCOME: Sympathetic activity is measured by detecting catecholamine (Epinephrine and Norepinephrine) and plasma free metanephrine (Metanephrine, Normetanephrine and Methoxytyramine) concentrations immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again. INCLUSION CRITERIA: 1. Aged 18 years or over 2. Severe neurological injury ‐ traumatic and non‐ traumatic injuries, requiring neurological, cardiovascular and respiratory functions monitoring 24/7 at the moment of the admission (for example subarachnoid hemorrhage, severe brain trauma, intra‐parenchymal hemorrhage, ischemic vascular accident, brain anoxia) 3. Bed rest for at least 7 days 4. Continuous monitoring in the Intermediate Care Unit 5. Signed informed consent SECONDARY OUTCOME: 1. Blood pressure is measured using a sphygmomanometer upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again; 2. Heart rate is measured using a heart rate montior upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again; 3. Respiratory rate is measured using an optical breath rate sensor upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed, during the first mobilization out of bed and one hour after lying in bed again; 4. Cerebral blood flow velocity is measured using a transcranial Doppler (for patients with subarachnoid hemorrhage only) upon admission to the Intermediate Care Unit, immediately before first mobilization out of bed and one hour after lying in bed again
Epistemonikos ID: 4f5ee5d85b4cd52c1062006cd30c1492a8cb136f
First added on: Aug 24, 2024