Quantitative Pupillometric evaluation to noxious stimulation for prognostication of patients with acute traumatic brain injury - A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NIMHANS
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Association between the magnitude of change in QPi (amplitude of photomotor reflex) to noxious stimulation assessed in the contralateral pupil (opposite to injured side) using automated pupillometry and neurological outcome assessed using Glasgow Outcome Scale Extended (GOSE)
研究概览
简要总结
The conventional neurological trauma assessment encompasses two primary components: the Glasgow Coma Scale (GCS) score and the pupillary evaluation. When compared to the application of Quantitative Pupillometry (QP), a 22% discrepancy rate among nurses has been demonstrated when detecting anisocoria. Pupillometry has been recently evaluated for prediction of neurological outcomes after TBI in the western population. These early studies have found pupillometry to be useful for outcome prediction.
The automated pupillometer (Neurolight®, IDMed Company, Marseilles, France) provides objective information about the baseline pupil diameter (PD) in mm, the variation in PD with light reflex (in %), the constriction velocity (CV), latency and Quantitative Pupillary Index or the amplitude of photomotor reflex (QPi), ranging from 0-5 (a composite score based on the reactivity of the pupil to light). With administration of painful stimulus, pupillary dilatation occurs and therefore, PD increases. Since, the PD increases, the change in PD with light stimulation, also increases with noxious stimuli. This would lead to increase in the variation, CV and also an increase in QPi.The role of pupillary reactivity to painful stimuli as a prognostic determinant has not been explored in patients with TBI. So in this study, we intend to evaluate prognostic ability of QP (based on pupillary reactivity to light stimulation) during noxious stimulus, in the pupil contralateral to the injured side in moderate to severe TBI patients in terms of Glasgow Outcome Scale Extended (GOSE).
Optic nerve sheath diameter (ONSD) is a tool for non-invasive estimation of ICP and may allow detection of increase in ICP.An increase in ONSD has also been shown to be associated with unfavourable outcome in patients with TBI. We also intend to study correlation of ONSD with QPi. Pain assessment by pupillometer is based on the principle that pupil dilates with application of noxious stimulation and pupillary light reflex amplitude (PLRA), which is the difference between PD before and after light exposure, increases after application of a noxious stimulus under general anaesthesia. This has been proven to be useful to assess pain in conscious adult patients. Although there is literature where pupillometer has been used to guide intraoperative analgesic administration, there is not much evidence on the effect of opioids on pupillary parameters which will also be explored in the study. As secondary outcomes, we also intend to explore correlation of pain assessment using BPS scoring, consciousness (BIS) and ICP with pupillometric parameters.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients (
- •75 years of age), with moderate to severe TBI admitted to Neuro ICU/ward within 48 hours of injury.
排除标准
- •Absence of feasibility of performing Quantitative Pupillometry(QP) and ONSD assessment on the eye contralateral to the side with significant TBI (contralateral eye with pupillary disease or significant periorbital oedema where pupillary assessment is not possible)
- •Patients for whom consent is not available
- •Patients with significant co-morbidities/ extra cranial injuries where these are likely to affect survival.
结局指标
主要结局
Association between the magnitude of change in QPi (amplitude of photomotor reflex) to noxious stimulation assessed in the contralateral pupil (opposite to injured side) using automated pupillometry and neurological outcome assessed using Glasgow Outcome Scale Extended (GOSE)
时间窗: 1. at discharge | 2. at 3 months
次要结局
- 1. Association between pupillary parameters other than QPi [pupillary diameter (PD), change in pupil diameter (measured as % variation), latency, constriction velocity (CV)] assessed using automated pupillometer during noxious stimulation, and neurological outcome assessed using m-GCS at hospital discharge, in-hospital mortality and GOSE after TBI in ICU and ward patients(2. Association between anisocoria and neurological outcome assessed using m-GCS at hospital discharge, in-hospital mortality and GOSE)
- 3.To determine the correlation between nurse assessed pupillary diameter before light reflex and baseline pupil diameter assessed with automated pupillometer in ICU(4. To assess the effect of opioid (if administered as part of sedoanalgesia) on QPi in ICU)
- 5.To evaluate the correlation between BPS and pupillary parameters after TBI during noxious stimulations such as tracheal suctioning and supraorbital pressure in ICU 6.To determine correlation of ONSD with QPi response to noxious stimuli in ICU(7.To determine correlation of change in depth of consciousness assessed on forehead contralateral to the injured side/ less injured side assessed using Bispectral Index (BIS) and hemodynamic parameters – heart rate and mean arterial pressure with the change in QPi in response to noxious stimuli in ICU)
研究者
Deeparaj L
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, Bangalore