scholarly journals Outcome Prognostication of Acute Brain Injury using the Neurological Pupil Index (ORANGE) study: protocol for a prospective, observational, multicentre, international cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e046948
Author(s):  
Mauro Oddo ◽  
Fabio Taccone ◽  
Stefania Galimberti ◽  
Paola Rebora ◽  
Giuseppe Citerio

IntroductionThe pupillary examination is an important part of the neurological assessment, especially in the setting of acutely brain-injured patients, and pupillary abnormalities are associated with poor outcomes. Currently, the pupillary examination is based on a visual, subjective and frequently inaccurate estimation. The use of automated infrared pupillometry to measure the pupillary light reflex can precisely quantify subtle changes in pupillary functions. The study aimed to evaluate the association between abnormal pupillary function, assessed by the Neurological Pupil Index (NPi), and long-term outcomes in patients with acute brain injury (ABI).Methods and analysisThe Outcome Prognostication of Acute Brain Injury using the Neurological Pupil Index study is a prospective, observational study including adult patients with ABI requiring admission at the intensive care unit. We aimed to recruit at least 420 patients including those suffering from traumatic brain injury or haemorrhagic strokes, over 12 months. The primary aim was to assess the relationship between NPi and 6-month mortality or poor neurological outcome, measured by the Extended Glasgow Outcome Score (GOS-E, poor outcome=GOS-E 1–4). Supervised and unsupervised methods and latent class mixed models will be used to identify patterns of NPi trajectories and Cox and logistic model to evaluate their association with outcome.Ethics and disseminationThe study has been approved by the institutional review board (Comitato Etico Brianza) on 16 July 2020. Approved protocol V.4.0 dated 10 March 2020. The results of this study will be published in peer-reviewed journals and presented at conferences.Trial registration numberNCT04490005.

Neurology ◽  
2020 ◽  
Vol 94 (19) ◽  
pp. e2054-e2068 ◽  
Author(s):  
David Y. Hwang ◽  
Andrea K. Knies ◽  
David Mampre ◽  
Stanislav Kolenikov ◽  
Marci Schalk ◽  
...  

ObjectiveTo determine whether groups of surrogates for patients with severe acute brain injury (SABI) with poor prognosis can be identified based on their prioritization of goals-of-care (GOC) decisional concerns, an online survey of 1,588 adults recruited via a probability-based panel representative of the US population was conducted.MethodsParticipants acted as a surrogate for a GOC decision for a hypothetical patient with SABI and were randomized to 1 of 2 prognostic scenarios: the patient likely being left with a range of severe functional disability (SD) or remaining in a vegetative state (VS). Participants prioritized a list of 12 decisional concerns via best-worst scaling. Latent class analysis (LCA) was used to discover decisional groups.ResultsThe completion rate was 44.6%; data weighting was conducted to mitigate nonresponse bias. For 792 SD respondents, LCA revealed 4 groups. All groups shared concerns regarding respecting patient wishes and minimizing suffering. The 4 groups were otherwise distinguished by unique concerns that their members highlighted: an older adult remaining severely disabled (34.4%), family consensus (26.4%), doubt regarding prognostic accuracy (20.7%), and cost of long-term care (18.6%). For the 796 VS respondents, LCA revealed 5 groups. Four of the 5 groups had similar concern profiles to the 4 SD groups. The largest (29.0%) expressed the most prognostic doubt. An additional group (15.8%) prioritized religious concerns.ConclusionsAlthough surrogate decision makers for patients with SABI are concerned with respecting patient wishes and minimizing suffering, certain groups highly prioritize other specific decisional factors. These data can help inform future interventions for supporting decision makers.


1998 ◽  
Vol 275 (4) ◽  
pp. R1287-R1292 ◽  
Author(s):  
Brahm Goldstein ◽  
Daniel Toweill ◽  
Susanna Lai ◽  
Karen Sonnenthal ◽  
Brent Kimberly

We hypothesized that acute brain injury results in decreased heart rate (HR) variability and baroreflex sensitivity indicative of uncoupling of the autonomic and cardiovascular systems and that the degree of uncoupling should be proportional to the degree of neurological injury. We used HR and blood pressure (BP) power spectral analysis to measure neuroautonomic regulation of HR and BP and the transfer function magnitude (TF) between BP and HR as a measure of baroreflex modulation of HR. In 24 brain-injured patients [anoxic/ischemic injury ( n = 7), multiple trauma ( n = 6), head trauma ( n = 5), central nervous system infection ( n = 4), and intracranial hemorrhage ( n = 2)], neurological injury and survival was associated with low-frequency (0.01–0.15 Hz) HR and BP power and TF. Brain-dead patients showed decreased low-frequency HR power [0.51 ± 0.36 (SE) vs. 2.54 ± 0.14 beats/min2, P = 0.03] and TF [0.61 ± 0.16 (SE) vs. 1.29 ± 0.07 beats ⋅ min−1 ⋅ mmHg−1, P = 0.05] compared with non-brain-dead patients. We conclude that 1) severity of neurological injury and outcome are inversely associated with HR and BP variability and 2) there is direct evidence for cardiovascular and autonomic uncoupling in acute brain injury with complete uncoupling during brain death.


2014 ◽  
Vol 2 ◽  
pp. 396-399 ◽  
Author(s):  
DJ Albers ◽  
J Claassen ◽  
M Schmidt ◽  
G Hripcsak

Therapy ◽  
2006 ◽  
Vol 3 (3) ◽  
pp. 399-405
Author(s):  
Elham Hadidi ◽  
Mojtaba Mojtahedzadeh ◽  
Mohammad Hassan Paknejad ◽  
Shekoufeh Nikfar ◽  
Mohammad Jafar Zamani ◽  
...  

Author(s):  
Eugene M Dempsey ◽  
Keith J Barrington ◽  
Neil Marlow ◽  
Colm Patrick Finbarr O'Donnell ◽  
Jan Miletin ◽  
...  

ObjectiveTo determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation.DesignDouble-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.Setting10 sites across Europe and Canada.ParticipantsInfants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage.InterventionParticipants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).Primary outcomeSurvival to 36 weeks of PMA without severe brain injury.ResultsThe trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038).ConclusionThough this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area.Trial registration numberNCT01482559, EudraCT 2010-023988-17.


2005 ◽  
Vol 20 (4) ◽  
pp. 394 ◽  
Author(s):  
V. Papaioannou ◽  
M. Giannakou ◽  
N. Maglaveras ◽  
E. Sofianos ◽  
M. Giala

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