瞳孔测量预测 ICU 谵妄（PODIUM）：一项前瞻性多中心队列研究方案。

PupillOmetry for preDIction of DeliriUM in ICU (PODIUM): protocol for a prospective multicentre cohort study.

机构信息

Intensive Care Unit, Delafontaine Hospital, Saint Denis, France

Research Clinic, Epidemiology, Biostatistic Department Bichat hospital, DMU PRISME, Assistance Publique des Hôpitaux de Paris Nord, Groupe Hospitalier Universitaire Paris Cité, Paris, France.

出版信息

BMJ Open. 2023 Jul 12;13(7):e072095. doi: 10.1136/bmjopen-2023-072095.

DOI:10.1136/bmjopen-2023-072095

PMID:37438060

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10347512/

Abstract

INTRODUCTION

Delirium is a severe complication that is associated with short-term adverse events, prolonged hospital stay and neurological sequelae in survivors. Automated pupillometry is an easy-to-use device that allows for accurate objective assessment of the pupillary light responses in comatose patients in the intensive care unit (ICU). Whether automated pupillometry might predict delirium in critically ill patients is not known. We hypothesise that automated pupillometry could predict the occurrence of delirium in critically ill patients without primary brain injury, requiring more than 48 hours of invasive mechanical ventilation in the ICU.

METHODS AND ANALYSIS

The PupillOmetry for preDIction of DeliriUM in ICU (PODIUM) study is a prospective cohort study, which will be conducted in eight French ICUs in the Paris area. We aim to recruit 213 adult patients requiring invasive mechanical ventilation for more than 48 hours. Automated pupillometry (Neurological Pupil Index; NPi-200, Neuroptics) will be assessed two times per day for 7 days. Delirium will be assessed using the Confusion Assessment Method in ICU two times per day over 14 days in non-comatose patients (Richmond Agitation and Sedation Scale ≥-3).The predictive performances of the seven automated pupillometry parameters (ie, pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses) measured to detect the delirium occurrence within 14 days will be the main outcomes. Secondary outcomes will be the predictive performances of the seven automated pupillometry parameters to detect complications related to delirium, ICU length of stay, mortality, functional and cognitive outcomes at 90 days.

ETHICS AND DISSEMINATION

The PODIUM study has been approved by an independent ethics committee, the Comité de Protection des Personnes (CPP) OUEST IV-NANTES (CPP21.02.15.45239 32/21_3) on 06 April 2021). Participant recruitment started on 15 April 2022. Results will be published in international peer-reviewed medical journals and presented at conferences.

TRIAL REGISTRATION NUMBER

NCT05248035; clinicaltrials.gov.

摘要

简介

谵妄是一种严重的并发症，与短期不良事件、住院时间延长和幸存者的神经后遗症有关。自动瞳孔测量是一种易于使用的设备，可在重症监护病房（ICU）中对昏迷患者的瞳孔光反应进行准确客观的评估。自动瞳孔测量是否可以预测危重症患者的谵妄尚不清楚。我们假设自动瞳孔测量可以预测无原发性脑损伤、需要在 ICU 中接受超过 48 小时有创机械通气的危重症患者发生谵妄。

方法和分析

瞳孔对 ICU 中谵妄的预测（PODIUM）研究是一项前瞻性队列研究，将在巴黎地区的八个法国 ICU 中进行。我们的目标是招募 213 名需要超过 48 小时有创机械通气的成年患者。每天两次使用自动瞳孔计（Neuroptics 的神经瞳孔指数；NPi-200）进行 7 天评估。在非昏迷患者（Richmond 躁动和镇静量表≥-3）中，使用 ICU 中的意识模糊评估方法每天两次评估 14 天内的谵妄。主要结局将是测量的七个自动瞳孔测量参数（即瞳孔直径、瞳孔直径变化、瞳孔收缩速度、瞳孔扩张速度、光运动反射潜伏期、NPi 和瞳孔反应的对称性）的预测性能，以检测 14 天内发生的谵妄。次要结局将是七个自动瞳孔测量参数预测谵妄相关并发症、ICU 住院时间、死亡率、90 天的功能和认知结局的预测性能。