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临床试验/NCT06219889
NCT06219889招募中不适用

Short-term And Longer-term Cognitive Impact Of Hourly Neurochecks In Acute Brain Injury

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Delirium Duration (short - term cognitive)

研究概览

简要总结

The proposed research plan seeks to understand the impact of sleep disruption in the Neurological Intensive Care Unit (ICU) on older patients with acute brain injury (ABI). In current practice, the neurocritical care community performs frequent serial neurological examinations ("neurochecks") in an effort to monitor patients for neurological deterioration following brain injury. Many neurocritical patients are older and/or cognitively fragile, and delirium is common. Although ICU delirium is multifaceted, frequent neurochecks may represent a modifiable risk factor if the investigators can better understand the risks and benefits of various neurocheck frequencies. This project will randomize patients with acute spontaneous intracerebral hemorrhage (ICH) to either hourly (Q1) or every-other-hour (Q2) neurochecks and evaluate the impact of neurocheck frequency on delirium. Second, longer-term cognitive outcomes will be investigated in patients with ICH randomized to Q1 versus Q2 neurochecks with the goal of identifying whether hourly neurochecks increase the risk for dementia.

详细描述

Usual care: Patients with ICH are cared for in the NeuroICU by a specialized team including Board-certified neurointensivists, nurse practitioners, and neuro-trained bedside nurses (neuroRNs). These neuroRNs each undergo intensive specialized training on the neurological exam, diagnosis, and acute management of neuro-complications, and maintain their knowledge via regular audits and through annual continuing education. The CAM-ICU tool is the most well-known and robustly utilized tool to assess ICU delirium, and has been validated in the poststroke population. The investigators have tight adherence to detailed protocols for multidisciplinary management of potential confounders including coagulopathy, cerebral edema, blood pressure (goal 130-150mmHg systolic), nutrition, glucose control, and early mobility. Pain management utilizes Tylenol and short-acting opiates in non-intubated patients. In intubated patients, our goal RASS (Richmond Agitation Sedation Score) is 0 to -2 and the investigators prioritize analgosedation with fentanyl, propofol and/or dexmedetomidine.

This intervention: Patients will be randomized (random number generator) to Q1 or Q2 neurochecks, which will be performed by the bedside expert neuroRNs. Once randomized, the investigators will monitor patients during their ICU admission with data prospectively collected to include: patient and clinical demographic information (e.g., age, severity and location of ICH), pre-admission sleep quality (via Pittsburgh Sleep Quality Index), medical complications during ICU admission, incident delirium per ICU stay (as measured by CAM-ICU screening tool performed by the bedside nurses each shift; yes/no) as well as time elapsed in the hospital prior to developing delirium, frequency of neurochecks at time of incident delirium, ICU and hospital lengths of stay (LOS), consecutive and total duration of delirium (as measured by CAM-ICU), discharge destination (including death), techniques used to manage delirium (e.g., antipsychotic medication administration with total dosages), and pharmacotherapy for pain (e.g., opiate frequency and dosing). Safety data (i.e., mortality, upgrade in frequency of neurochecks, adverse events) will be collected throughout the study (see details in DSMP). Given a reported association between ApoE allele and early onset delirium and delirium duration, all enrolled patients will undergo saliva sampling (4 buccals swabs) for ApoE allele status.

Long-term outcomes:

Patients enrolled in will be followed longitudinally for longer-term neuropsychological assessment at 6-months post-discharge. Assessment will be performed using the comprehensive cognitive and emotional batteries through NIH Toolbox® along with supplemental cognitive measures (e.g., Auditory Verbal Learning, AVLT) and additional mood/emotional screening questionnaires (e.g., HAM-A, IES-R). The NIH Toolbox® is chosen because of its validation in neurological patients with stroke and relative resilience against learning effects. By giving a wide range of verbal and nonverbal tests and using typical methods of cognitive assessment (e.g., delayed AVLT), the investigators can address our outcomes independent of verbal dysfunction from dominant hemisphere lesions and over time as a function of domain-specific impairments. This aim will also capture retention statistics and participant impressions/willingness to participate after 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients (age >18 years) with spontaneous acute <45cc in volume with radiographic and clinical stability for ≥6 hours following admission to the ICU. These criteria are based on the literature and experience of the investigative team.
  • •Additional intraventricular hemorrhage (with or without external ventricular drain) is allowable.
  • •Only first admission to the NeuroICU during the hospitalization will be eligible.
  • •Inclusion criteria (Part 2):
  • •a. any patient included in part 1 alive at 6 months post-discharge

排除标准

  • •Patients with unstable intracranial bleeding
  • •Patients with known history of intracranial neurological injury
  • •Pre-existing cognitive impairment (known or highly suspected based on family-provided history, Activities of Daily Living Questionnaire)
  • •Pre-existing diagnosed sleep disorder
  • •Comatose or heavily sedated
  • •Death expected within 30 days or other terminal illness
  • •ICH score >4 (equivalent to mortality risk >72%)
  • •Incarcerated
  • •Non-English or non-Spanish speaking

研究组 & 干预措施

Hourly Neurochecks

Active Comparator

Patients will be awakened hourly for their examinations

干预措施: Frequency of neurochecks (Behavioral)

Every-Other-Hour Neurochecks

Experimental

Patients will be awakened every other hour for their examinations

干预措施: Frequency of neurochecks (Behavioral)

结局指标

主要结局

Delirium Duration (short - term cognitive)

时间窗: No more than 6 months after date of admission to ICU

Cumulative duration (in multiple of 0.5 days) of incident delirium

Long-term cognitive function

时间窗: 6-month follow-up

NIH Toolbox: demographically corrected fluid cognition composite score

次要结局

  • Incident delirium(No more than 6 months after date of admission to ICU)
  • Intensive care unit (ICU) length of stay(No more than 6 months after date of admission to ICU)
  • Discharge destination(No more than 6 months after date of admission to ICU)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie Labuzetta

Clinical Professor of Neurosciences

University of California, San Diego

研究点 (2)

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