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

Details

Serval ID
serval:BIB_3A4060511EBA
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Outcome Prognostication of Acute Brain Injury using the Neurological Pupil Index (ORANGE) study: protocol for a prospective, observational, multicentre, international cohort study.
Journal
BMJ open
Author(s)
Oddo M., Taccone F., Galimberti S., Rebora P., Citerio G.
Working group(s)
Orange Study Group
Contributor(s)
Badenes R., Bouzat P., Caricato A., Chesnut R.M., Hemphill C., Rasulo F., Schwab S., Suarez J.I., Sunde K., Blandino A., Malgeri L., Rossi E., Vargiolu A., Elli F., Graziano F.
ISSN
2044-6055 (Electronic)
ISSN-L
2044-6055
Publication state
Published
Issued date
11/05/2021
Peer-reviewed
Oui
Volume
11
Number
5
Pages
e046948
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
The 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).
The 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.
The 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.
NCT04490005.
Keywords
adult intensive & critical care, neurological injury, stroke
Pubmed
Open Access
Yes
Create date
29/05/2021 12:27
Last modification date
07/07/2021 6:36
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