Automated Pupillometry for Coma Prognostication After Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 10
- 主要终点
- Neurological outcome
研究概览
简要总结
Background: Sedation and therapeutic hypothermia (TH) delay neurological responses and might reduce the accuracy of clinical examination to predict outcome after cardiac arrest (CA). Electroencephalography (EEG) and somato-sensory evoked potentials (SSEP) might significantly improve prognostication of post-CA coma, however, EEG and SSEP are not always available and require specific expertise for their interpretation. Automated video pupillometry is a novel electronic device that contains an infrared light camera which enables to measure quantitatively the percentage of pupillary reaction to a calibrated light stimulation. In a recent study of a cohort of comatose CA survivors (n=50 patients) it was found that quantitative PLR was more accurate than standard PLR (manual pen light) in predicting 3-month outcome, irrespective of temperature and sedation, and had comparable prognostic accuracy than electrophysiological exams, including electroencephalography (EEG) and somato-sensory evoked potentials (SSEP).
Aim of the study: In light of these promising results, the investigators would like to confirm the prognostic value of quantitative PLR in a large multicenter cohort of comatose post-CA patients.
Design of the study: Prospective, multicenter, observational outcome trial.
详细描述
Study: Prospective, multicenter study. The study will be double-blinded, i.e. the clinician/nurse performing the tests will not be involved in patient care and clinicians in charge of patients will not be aware of automated pupillometry data. Patient care will not be influenced by pupillometry.
Patient population:
The investigators plan to include 500 comatose post-CA patients. The centers have been selected based on their expertise and publication track record on the topic, and because they are actively involved in the Neurointensive Care section (NIC) of the European Society of Intensive Care Medicine (ESICM). The study will take place at the Department of Intensive Care of the participating centers.
Patients will be managed according to standards of post-resuscitation care and based on local algorithms for the treatment of post-CA coma.
Quantitative pupillary light reactivity (PLR, using the NeurOptics NPi-200 pupillometer) will be performed on ICU admission and then every 12 hours up to 72 hours after CA. At each time point, one measurement will be assessed on both eyes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with coma after cardiac arrest (CA)
- •Glasgow Coma Scale (at inclusion): ≤ 6
- •Patients with CA due to ventricular fibrillation (VF) and non-VF (including asystole and pulseless electrical activity) rhythms
- •Cardiac and non-cardiac causes of CA will be included
排除标准
- •Age < 18 years
- •Unable to obtain consent
- •Follow-up unavailable
结局指标
主要结局
Neurological outcome
时间窗: 3-6 months
Neurological outcome is assessed by a semi-structured telephone interview with the patient or the patient's relatives using the Glasgow-Pittsburgh Cerebral Performance Categories (CPC). The CPC result is then categorized as favorable outcome (CPC 1-2, including good recovery and moderate disability), vs. unfavorable outcome (CPC 3-5, including severe disability, vegetative state and death).
次要结局
未报告次要终点
研究者
Mauro ODDO
Médecin adjoint, PD-MER I
Centre Hospitalier Universitaire Vaudois