scholarly journals Early Orthostatic Exercise by Head-Up Tilt With Stepping vs. Standard Care After Severe Traumatic Brain Injury Is Feasible

2021 ◽  
Vol 12 ◽  
Author(s):  
Christian Gunge Riberholt ◽  
Markus Harboe Olsen ◽  
Christian Baastrup Søndergaard ◽  
Christian Gluud ◽  
Christian Ovesen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Adverse Events ◽  
Severe Traumatic Brain Injury ◽  
Standard Care ◽  
Randomized Clinical Trials ◽  
Neurointensive Care ◽  
Control Group ◽  
Neurointensive Care Unit

Background: Intensive rehabilitation of patients after severe traumatic brain injury aims to improve functional outcome. The effect of initiating rehabilitation in the early phase, in the form of head-up mobilization, is unclear.Objective: To assess whether early mobilization is feasible and safe in patients with traumatic brain injury admitted to a neurointensive care unit.Methods: This was a randomized parallel-group clinical trial, including patients with severe traumatic brain injury (Glasgow coma scale <11 and admission to the neurointensive care unit). The intervention consisted of daily mobilization on a tilt-table for 4 weeks. The control group received standard care. Outcomes were the number of included participants relative to all patients with traumatic brain injury who were approached for inclusion, the number of conducted mobilization sessions relative to all planned sessions, as well as adverse events and reactions. Information on clinical outcome was collected for exploratory purposes.Results: Thirty-eight participants were included (19 in each group), corresponding to 76% of all approached patients [95% confidence interval (CI) 63–86%]. In the intervention group, 74% [95% CI 52–89%] of planned sessions were carried out. There was no difference in the number of adverse events, serious adverse events, or adverse reactions between the groups.Conclusions: Early head-up mobilization is feasible in patients with severe traumatic brain injury. Larger randomized clinical trials are needed to explore potential benefits and harms of such an intervention.Clinical Trial Registration: [ClinicalTrials.gov], identifier [NCT02924649]. Registered on 3rd October 2016.

scholarly journals A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury

2013 ◽  
Vol 118 (6) ◽  
pp. 1317-1328 ◽  
Author(s):  
Sarah B. Rockswold ◽  
Gaylan L. Rockswold ◽  
David A. Zaun ◽  
Jiannong Liu
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Intracranial Pressure ◽  
Clinical Outcome ◽  
Severe Traumatic Brain Injury ◽  
Standard Care ◽  
Cerebral Metabolism ◽  
Control Group ◽  
Normobaric Hyperoxia

Object Preclinical and clinical investigations indicate that the positive effect of hyperbaric oxygen (HBO2) for severe traumatic brain injury (TBI) occurs after rather than during treatment. The brain appears better able to use baseline O2 levels following HBO2 treatments. In this study, the authors evaluate the combination of HBO2 and normobaric hyperoxia (NBH) as a single treatment. Methods Forty-two patients who sustained severe TBI (mean Glasgow Coma Scale [GCS] score 5.7) were prospectively randomized within 24 hours of injury to either: 1) combined HBO2/NBH (60 minutes of HBO2 at 1.5 atmospheres absolute [ATA] followed by NBH, 3 hours of 100% fraction of inspired oxygen [FiO2] at 1.0 ATA) or 2) control, standard care. Treatments occurred once every 24 hours for 3 consecutive days. Intracranial pressure, surrogate markers for cerebral metabolism, and O2 toxicity were monitored. Clinical outcome was assessed at 6 months using the sliding dichotomized Glasgow Outcome Scale (GOS) score. Mixed-effects linear modeling was used to statistically test differences between the treatment and control groups. Functional outcome and mortality rates were compared using chi-square tests. Results There were no significant differences in demographic characteristics between the 2 groups. In comparison with values in the control group, brain tissue partial pressure of O2 (PO2) levels were significantly increased during and following combined HBO2/NBH treatments in both the noninjured and pericontusional brain (p < 0.0001). Microdialysate lactate/pyruvate ratios were significantly decreased in the noninjured brain in the combined HBO2/NBH group as compared with controls (p < 0.0078). The combined HBO2/NBH group's intracranial pressure values were significantly lower than those of the control group during treatment, and the improvement continued until the next treatment session (p < 0.0006). The combined HBO2/NBH group's levels of microdialysate glycerol were significantly lower than those of the control group in both noninjured and pericontusional brain (p < 0.001). The combined HBO2/NBH group's level of CSF F2-isoprostane was decreased at 6 hours after treatment as compared with that of controls, but the difference did not quite reach statistical significance (p = 0.0692). There was an absolute 26% reduction in mortality for the combined HBO2/NBH group (p = 0.048) and an absolute 36% improvement in favorable outcome using the sliding dichotomized GOS (p = 0.024) as compared with the control group. Conclusions In this Phase II clinical trial, in comparison with standard care (control treatment) combined HBO2/NBH treatments significantly improved markers of oxidative metabolism in relatively uninjured brain as well as pericontusional tissue, reduced intracranial hypertension, and demonstrated improvement in markers of cerebral toxicity. There was significant reduction in mortality and improved favorable outcome as measured by GOS. The combination of HBO2 and NBH therapy appears to have potential therapeutic efficacy as compared with the 2 treatments in isolation. Clinical trial registration no.: NCT00170352 (ClinicalTrials.gov).

scholarly journals Statistical analysis plan for early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – a randomised clinical feasibility trial

2019 ◽  
Author(s):  
Christian Gunge Riberholt ◽  
Christian Gluud ◽  
Janus Christian Jakobsen ◽  
Christian Ovesen ◽  
Jesper Mehlsen ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Statistical Analysis ◽  
Brain Injury ◽  
Adverse Events ◽  
Severe Traumatic Brain Injury ◽  
Standard Care ◽  
Statistical Analysis Plan ◽  
Feasibility Trial ◽  
Early Mobilisation ◽  
Head Up Tilt

Abstract Background: Early mobilisation on a tilt table with stepping versus standard care may be beneficial for patients with severe brain injury, but data from randomised clinical trials are lacking. Methods: This detailed statistical analysis plan describes the analyses of data collected in a randomised clinical feasibility trial for early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury. Primary feasibility outcomes are the proportion of included participants who were randomised out of all screened patients; the proportion of participants allocated to the experimental intervention who received at least 60% of the planned exercise sessions; and safety outcomes such as adverse events and reactions and serious adverse events and reactions. Exploratory clinical outcomes are suspected unexpected serious adverse reactions; and functional outcomes as assessed by Coma Recovery Scale – Revised at four weeks; Early Functional Ability Scale and Functional Independence Measure at three months. The description includes the statistical analyses including use of multiple imputation and Trial Sequential Analysis. Conclusions: The present statistical analysis plan serves to minimise potential trial reporting bias and selective P hacking and to improve transparency. This trial will inform the feasibility of a potential future multicentre randomised clinical trial. Trial registration: ClinicalTrials.gov identifier: NCT02924649. Registered on 3 October 2016.

scholarly journals Hyperbaric oxygen for severe traumatic brain injury: a randomized trial

2020 ◽  
Vol 48 (10) ◽  
pp. 030006052093982
Author(s):  
Xianliang Zhong ◽  
Aijun Shan ◽  
Jianzhong Xu ◽  
Jian Liang ◽  
Ying Long ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Hyperbaric Oxygen ◽  
Severe Traumatic Brain Injury ◽  
Hyperbaric Oxygen Therapy ◽  
Oxygen Therapy ◽  
Vital Signs ◽  
Neurological Function ◽  
Control Group ◽  
Experimental Group

Objective The present study aimed to explore the effects of hyperbaric oxygen therapy on the prognosis and neurological function of patients with severe traumatic brain injury. Methods A prospective study was carried out in 88 patients diagnosed with severe brain injury at our hospital and they were enrolled as research participants and randomly assigned to control and experimental groups (n = 44 per group) using a random number table method. Both groups underwent routine treatment. Patients in the experimental group were administered hyperbaric oxygen therapy approximately 1 week after admission when their vital signs had stabilized. Results No significant intergroup differences were observed in the Glasgow Coma Scale (GCS) and U.S. National Institutes of Health Stroke Scale (NIHSS) scores before treatment. However, after oxygen treatment, compared with the control group, the experimental group showed higher GCS and lower NIHSS scores. The GCS score at admission, tracheotomy status, and first hyperbaric oxygen therapy duration were independent prognostic factors in patients with severe traumatic brain injury. Conclusion Hyperbaric oxygen therapy may promote recovery of neurological function and improve the cognitive function and prognosis of patients with severe traumatic brain injury.

Respiratory, Physical, and Psychological Benefits of Breath-Focused Yoga for Adults with Severe Traumatic Brain Injury (TBI): A Brief Pilot Study Report

2012 ◽  
Vol 22 (1) ◽  
pp. 47-52 ◽  
Author(s):  
Colin Silverthorne ◽  
Sat Bir Khalsa ◽  
Robin Gueth ◽  
Nicole DeAvilla ◽  
Janie Pansini
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Pilot Study ◽  
Severe Traumatic Brain Injury ◽  
Well Being ◽  
Small Sample ◽  
Longitudinal Change ◽  
Control Group ◽  
Psychological Well Being ◽  
Severe Tbi

Objective: This pilot study was designed to identify the potential benefits of breath-focused yoga on respiratory, physical, and psychological functioning for adults with severe traumatic brain injury (TBI). Participants: Ten individuals with severe TBI who self-selected to attend weekly yoga classes and 4 no-treatment controls were evaluated. Methods: Participants were assessed at pretreatment baseline and at 3-month intervals for a total of 4 time points over 40 weeks. Outcomes of interest included observed exhale strength, ability to hold a breath or a tone, breathing rate, counted breaths (inhale and exhale), and heart rate, as well as self-reported physical and psycho-logical well-being. Results: Repeated within-group analyses of variance revealed that the yoga group demonstrated significant longitudinal change on several measures of observed respiratory functioning and self-reported physical and psychological well-being over a 40-week period. Those in the control group showed marginal improvement on 2 of the 6 measures of respiratory health, physical and social functioning, emotional well-being, and general health. The small sample sizes precluded the analysis of between group differences. Conclusion: This study provides preliminary evidence that breath-focused yoga may improve respiratory functioning and self-perceived physical and psychological well-being of adults with severe TBI.

HYPEREMIA BENEATH EVACUATED ACUTE SUBDURAL HEMATOMA IS FREQUENT AND PROLONGED IN PATIENTS WITH AN UNFAVORABLE OUTCOME

Neurosurgery ◽  
2009 ◽  
Vol 64 (4) ◽  
pp. 705-718 ◽  
Author(s):  
Arturo Chieregato ◽  
Alberto Noto ◽  
Alessandra Tanfani ◽  
Giovanni Bini ◽  
Costanza Martino ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Severe Traumatic Brain Injury ◽  
Subdural Hematoma ◽  
Time Course ◽  
Unfavorable Outcome ◽  
Acute Subdural Hematoma ◽  
Control Group ◽  
Computed Tomographic ◽  
The Mean

Abstract OBJECTIVE To verify the values and the time course of regional cerebral blood flow (rCBF) in the cortex located beneath an evacuated acute subdural hematoma (SDH) and their relationship with neurological outcome. METHODS rCBF levels were measured in multiple regions of interest, by means of a Xe-computed tomographic technique, in the cortex underlying an evacuated SDH and contralaterally in 20 patients with moderate or severe traumatic brain injury and an evacuated acute SDH. Twenty-three patients with moderate or severe traumatic brain injury and an evacuated extradural hematoma or diffuse injury served as the control group. Outcome was evaluated by means of the Glasgow Outcome Scale at 12 months. RESULTS Values for the maximum (rCBFmax) and the mean of all rCBF levels in the cortex beneath the evacuated SDH were more frequently consistent with hyperemia. The side-to-side differences in the mean of all rCBF and rCBFmax levels between lesioned and nonlesioned hemispheres were greater in patients with evacuated SDH than in controls (P = 0.0013 and P = 0.0018, respectively). The side-to-side difference in the maximum rCBF value was higher in SDH patients with unfavorable outcomes than in controls at 24 to 96 hours and at 4 to 7 days and higher than in patients with favorable outcomes at 4 to 7 days. The widest side-to-side difference in rCBFmax value was more elevated in patients with an evacuated SDH with unfavorable outcome than in patients with a favorable outcome (P = 0.047), whereas no differences were found in controls. The SDH thickness and the associated midline shift were greater in patients with unfavorable outcomes than in those with favorable outcomes. CONCLUSION On average, hyperemic long-lasting rCBF values frequently occur in the cortex located beneath an evacuated SDH and seem to be associated with unfavorable outcome.

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