Matteo Petrosino, PhD1,2; Elisa Gouvêa Bogossian, MD, PhD3; Paola Rebora, PhD1,2,4; et al
2024년 12월 9일
JAMA Neurol. Published online December 9, 2024. doi:10.1001/jamaneurol.2024.4189
Abstract
Importance
Invasive intracranial pressure (ICP) is the standard of care in patients with acute brain injury (ABI) with impaired consciousness. The Neurological Pupil Index (NPi) obtained by automated pupillometry is promising for noninvasively estimating ICP.
Objective
To evaluate the association between repeated NPi and invasive ICP values.
Design, Setting, and Participants
This study is a secondary analysis of the Outcome Prognostication of Acute Brain Injury With the Neurological Pupil Index (ORANGE), a multicenter, prospective, observational study of patients with ABI performed from October 1, 2020, to May 31, 2022, with follow-up at 6 months after ABI. The ORANGE study was performed at neurologic intensive care units of tertiary hospitals in Europe and North America. In ORANGE, 514 adult patients receiving mechanical ventilatory support were admitted to the intensive care unit after ABI.
Exposure
Invasive ICP monitoring and automated pupillometry assessment every 4 hours during the first 7 days, considered as a standard of care.
Main Outcomes and Measures
Association between ICP and NPi values over time, using bayesian joint models, with linear and logistic mixed-effects longitudinal submodels.
Results
The study included 318 adult patients (median [IQR] age, 58 [43-69] years; 187 [58.8%] male) who required intensive care unit admission, intubation, and mechanical ventilatory support due to acute traumatic brain injury (n = 133 [41.8%]), intracerebral hemorrhage (n = 104 [32.7%]), or aneurysmal subarachnoid hemorrhage (n = 81 [25.5%]) and had automatic infrared pupillometry used as part of the standard evaluation practice and ICP monitoring. A total of 8692 ICP measurements were collected, with a median (IQR) of 31 (18-37) evaluations per patient. The median (IQR) NPi and ICP for the study population were 4.1 (3.5-4.5) and 10 (5-14) mm Hg, respectively. In a linear mixed model, the mean change in the NPi value, as a continuous variable, was −0.003 (95% credible interval [CrI], −0.006 to 0.000) for each 1-mm Hg ICP increase. No significant association between ICP and abnormal NPi (<3; odds ratio, 1.01; 95% CrI, 0.99-1.03) or absent NPi (0; odds ratio, 1.03; 95% CrI, 0.99-1.06) was observed.
Conclusions and Relevance
Although an abnormal NPi could indicate brainstem dysfunction, in this large and heterogeneous population of patients, NPi values were not significantly associated overall with ICP values. Repeated NPi measurements may not be a sufficient replacement for invasive monitoring.
Trial Registration
ClinicalTrials.gov Identifier: NCT04490005
Key Points
Question Is there an association between paired Neurological Pupil Index (NPi) assessed by automated pupillometry and invasive intracranial pressure (ICP) values in patients with acute brain injury?
Findings This preplanned secondary analysis of the observational, multicenter ORANGE study included 318 patients and did not find any clinically significant association between ICP and NPi values assessed as continuous variables. There was also no clinically significant association between ICP as a continuous variable and dichotomized abnormal NPi values or between ICP and absent NPi.
Meaning In this study on patients with subarachnoid hemorrhage, traumatic brain injury, and intracerebral hemorrhage, repeated NPi measurements are insufficient to replace invasive monitoring.
요약
소개
급성 뇌손상 환자에서 자동 동공 측정을 통해 평가한 신경학적 동공 지수(Neurological Pupil Index, NPi)와 침습적인 두개내압(Intracranial Pressure, ICP) 값 사이의 연관성을 평가하고자 하는 연구이다. 침습적인 두개내압(ICP)은 의식 저하가 있는 급성 뇌손상(ABI) 환자에서 표준 치료법이고, 자동 동공 측정을 통해 얻은 신경학적 동공 지수(NPi)는 비침습적으로 두개내압을 추정하는 데 유망한 방법으로 알려져 있다.
방법
이 연구는 신경학적 동공 지수(NPI)를 이용한 급성 뇌손상 예후 예측(ORANGE) 연구의 2차 분석연구로, ORANGE 연구는 2020년 10월 1일부터 2022년 5월 31일까지 수행된 다기관, 전향적, 관찰 연구로, 급성 뇌손상(ABI) 환자들을 대상으로 하였으며, ABI 발생 후 6개월까지 추적 관찰을 진행한 연구이다. 이 연구에서는 시간이 지남에 따라 두개내압(ICP)과 신경학적 동공 지수(NPi) 값 사이의 연관성을 베이지안 결합 모델을 사용하여 평가했으며, 선형 및 로지스틱 혼합 효과 장기 추적 하위 모델을 적용했다.
결과
이 사전 계획된 2차 분석은 관찰적 다기관 연구인 ORANGE 연구에 포함된 318명의 환자를 대상으로 진행되었으며, ICP와 NPi 값 사이에 연속 변수로 평가했을 때 임상적으로 유의미한 연관성은 발견되지 않았다. 또한, ICP를 연속 변수로 사용했을 때 이분법적으로 나눈 비정상 NPi(abnormal NPi) 값 또는 NPi 결여(absent NPi)와의 임상적으로 유의미한 연관성도 없었다.
결론 및 의의
이 연구는 지주막하 출혈, 외상성 뇌손상, 뇌내 출혈 환자들을 대상으로 하였으며, 해당 환자들에게 반복적인 NPi 측정만으로는 침습적 ICP 모니터링을 대체하기에 충분하지 않다는 것을 시사한다.
#ICP, #Acute brain injury, #Neurological Pupil index, #NPi