Short-term And Longer-term Cognitive Impact Of Neurochecks
- Conditions
- Intracerebral Hemorrhage
- Interventions
- Behavioral: Frequency of neurochecks
- Registration Number
- NCT06219889
- Lead Sponsor
- University of California, San Diego
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
- 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%)
- Pregnancy
- Incarcerated
- Non-English or non-Spanish speaking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Every-Other-Hour Neurochecks Frequency of neurochecks Patients will be awakened every other hour for their examinations Hourly Neurochecks Frequency of neurochecks Patients will be awakened hourly for their examinations
- Primary Outcome Measures
Name Time Method Delirium Duration (short - term cognitive) 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 6-month follow-up NIH Toolbox: demographically corrected fluid cognition composite score
- Secondary Outcome Measures
Name Time Method Incident delirium No more than 6 months after date of admission to ICU Delirium that developed once the participant was admitted to the hospital
Intensive care unit (ICU) length of stay 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
Discharge destination No more than 6 months after date of admission to ICU The location to which the patient is discharged, including death
Trial Locations
- Locations (1)
UC San Diego Health
🇺🇸San Diego, California, United States