UC San Diego Health
San Diego, California, 92103, United States
Location status: Recruiting
NCT Number: NCT06219889
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
San Diego, California, 92103, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(Part 1):
Inclusion criteria
(Part 2):
a. any patient included in part 1 alive at 6 months post-discharge
Exclusion criteria
the frequency with which a patient is awakened to perform serial examinations
Time frame: No more than 6 months after date of admission to ICU
Cumulative duration (in multiple of 0.5 days) of incident delirium
Time frame: 6-month follow-up
NIH Toolbox: demographically corrected fluid cognition composite score
Time frame: No more than 6 months after date of admission to ICU
Length of time spent in the ICU from time of ICU admission through time of ICU discharge
Time frame: No more than 6 months after date of admission to ICU
Delirium that developed once the participant was admitted to the hospital
Time frame: No more than 6 months after date of admission to ICU
The location to which the patient is discharged, including death
Time frame: 6-month follow-up
Measured by Patient Health Questionnaire 9 (PHQ-9); min score 0 and max score 27 with higher scores denoting more severe depression
Time frame: 6-month follow-up
Measured by Hamilton Anxiety Rating Scale (HAM-A); higher scores (min 0, max 56) denote more severe anxiety
Time frame: 6-month follow-up
Measured by Impact of Event Scale-Revised (IES-R), which includes 3 subscales (intrusion, avoidance, hyperarousal) with higher scores denoting worse symptoms.
Contact information is provided by the study sponsor or research team.
University of California, San Diego
Other
Short-term And Longer-term Cognitive Impact Of Hourly Neurochecks In Acute Brain Injury
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