Exploratory Study on the Role of Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Correlation between neurological pupil index (NPi) and Post-operative delirium
研究概览
简要总结
The rate of postoperative delirium in patients who underwent cardiac surgery is very high. Different predictors and/or scores were studied for the prediction of Post Operative Delirium (POD)after heart surgery, but none of them was validated. The investigators aim to explore the role of pupillary alterations during anesthesia in open-heart surgery.
The goal of this prospective study is to evaluate if pupil alterations during cardiac surgery, evaluated by an automated pupillometer (NPi-200) ( AP), could predict postoperative delirium.
详细描述
Consent was obtained during the hospitalization before the planned surgery.
On the day of surgery, before general anesthesia is started, Near-infrared spectroscopy (NIRS) sensors are applied to the patient's forehead bilaterally and the baseline value is recorded. Pupils' variables (i.e., diameter, % constriction, constriction velocity, dilation velocity, latency, NPi) are also recorded from both the right and left eye with AP (NPi-200).
From the induction of anesthesia, pupillary variables in both eyes are recorded and measured every 30' such as the concomitant NIRS values (at least one measurement per eye per operative phase). Moreover, hemodynamic and respiratory parameters concomitant with the pupillary measurements are measured.
Following surgery, the patient is transferred to the Cardiac Intensive Care Unit. There, NIRS monitoring as as well as automated pupillometry measurements will be maintained until the patient regains consciousness (defined as RASS sedation scale >-3).
Once the patient has regained consciousness (RASS>-3), is assessed twice a day (morning and afternoon) with the Confusion assessment method-intensive care unit (CAM-ICU) score by the nursing staff and/or medical staff. The presence or absence of POD will then be reported as well as any pharmacological and non-pharmacological treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 undergoing elective open cardiac surgery (>18 yr)
- •Elective open cardiac surgery and cardiopulmonary bypass
排除标准
- •Patients <18 years of age
- •Emergency surgeries
- •Heart operations, not including extracorporeal circulation
- •Surgery for aortic arch dissection with hypothermia and/or circulatory arrest
- •Patients affected by psychiatric disorders undergoing with or without neuroleptic therapy
- •Patients who have the refused consent
- •Patients with ocular problems (acute or previous trauma to one or both eyes, blindness, ocular prosthesis)
研究组 & 干预措施
Patients undergoing open heart surgery
干预措施: Automated pupillometer NPi-200 (Device)
结局指标
主要结局
Correlation between neurological pupil index (NPi) and Post-operative delirium
时间窗: Intraoperative (day 0)
We want to relate pupillary reactivity, assessed with automated pupillometry such as the Neurological pupil index (numerical value:0-5) during surgery, with Postoperative delirium (assessed with CAM-ICU score during the first 5 postoperative days).
次要结局
- Multivariate model for POD prediction.(Day 0)
- Correlation between regional cerebral saturation (rSO2) and POD occurrence(rSO2 is monitored during surgery (Day 0))
- Correlation between early prediction model for delirium (E-PRE-DELIRIC) and POD(E-PREDELIRIC is calculated at ICU admission ( day 0))
- Correlation between Cardiopulmonary bypass duration and POD.(Intraoperative)