Neurochecks for Brain Injury

Overseen By Jamie N LaBuzetta

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Unstable bleeding, Cognitive impairment, Comatose, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: ICU length of stay (up to 6 months)

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Frequency of neurochecks for brain injury?

The research indicates that while neurochecks are commonly used to detect changes in brain function after an injury, there is limited scientific study on their effectiveness, especially in conditions like stroke. There is a need for more rigorous evaluation to understand their benefits and risks, including potential sleep disruption. ^{1 2 3 4 5}

Is it safe to participate in clinical trials involving neurochecks for brain injury?

The research articles provided do not contain specific safety data about neurochecks or similar neurological assessments for brain injury, so there is no relevant safety information available from these studies. ^{3 6 7 8 9}

How is the treatment of neurochecks for brain injury different from other treatments?

Neurochecks involve frequent neurological exams to monitor brain function, which is unique because it focuses on early detection of changes rather than direct intervention. Unlike other treatments that may involve medication or surgery, neurochecks are non-invasive and rely on regular assessments to prevent further injury, though they may disrupt sleep and contribute to additional issues like delirium. ^{1 2 4 10 11}

Eligibility Criteria

This trial is for older patients in the ICU with acute brain injuries from conditions like bleeding or stroke. It's looking at how often they should be checked for changes in their condition (neurochecks). Patients must not have other factors that could cause delirium, and they need to be able to participate in follow-up tests.

Inclusion Criteria

I have had bleeding in my brain's ventricles, with or without a drain.

I am over 55 and have a stable brain bleed between 10cc and 40cc.

Only first admission to the NeuroICU during the hospitalization will be eligible.

Exclusion Criteria

Pregnancy

I have unstable bleeding in my brain.

I have had a brain injury in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients are randomized to hourly or every-other-hour neurochecks during their ICU stay to monitor the impact on delirium and cognitive outcomes.

ICU length of stay (up to 6 months)

Continuous monitoring during ICU admission

Follow-up

Participants are monitored for long-term cognitive outcomes and other psychological measures at 6 months post-discharge.

6 months

1 visit (in-person or virtual) for cognitive assessment

Treatment Details

Interventions

• Frequency of neurochecks

Trial Overview The study is testing if checking patients every hour (hourly neurochecks) versus every two hours affects their short-term risk of developing delirium and long-term cognitive health, potentially impacting dementia risk after a brain injury.

Participant Groups

Group I: Every-Other-Hour Neurochecks Experimental Treatment 1 Intervention

Patients will be awakened every other hour for their examinations

Group II: Hourly Neurochecks Active Control 1 Intervention

Patients will be awakened hourly for their examinations

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Findings from Research

Frequent neurological examinations, or 'neurochecks', are essential for monitoring patients after acute brain injury, but they may inadvertently cause additional harm by disrupting sleep.

There is a significant gap in research regarding the patterns of neurological decline and the long-term effects of these frequent assessments, highlighting the need for better evaluation and optimization of neurocheck practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reassessing hourly neurochecks. LaBuzetta, JN., Kamdar, BB., Malhotra, A.[2023]

A survey of 177 healthcare providers revealed that both ordering and performing providers preferred every-other-hour neurochecks for patients with acute brain injury, rather than hourly checks, indicating a consensus on reducing frequency for better patient care.

Ordering providers expressed concerns that hourly neurochecks could be detrimental to patients, while performing providers felt guidelines should be more prescriptive, highlighting a significant difference in attitudes towards the frequency and necessity of these assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocheck Frequency: Determining Perceptions and Barriers to Implementation of Evidence-Based Practice. LaBuzetta, JN., Kazer, MR., Kamdar, BB., et al.[2023]

In a study of 227 patients with mild to moderate head trauma, abnormal neurological examinations were found to be the most reliable indicators of brain injuries and skull fractures, with a sensitivity of 87% for brain injuries and 77% for skull fractures.

Specific neurological signs, such as gait abnormalities and disturbances in consciousness, were the strongest predictors of cerebral lesions, suggesting that careful clinical assessment could help reduce unnecessary CT scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the reliability of clinical examination in predicting traumatic cerebral lesions and skull fractures in patients with mild and moderate head trauma. Zyluk, A., Mazur, A., Piotuch, B., et al.[2019]

In a study of 231 patients with acute ischemic stroke, neurochecks detected neurological deterioration in 45% of cases during scheduled assessments, highlighting their usefulness in monitoring patient status.

However, 29% of neurological deteriorations went undetected, indicating a need for improved monitoring strategies beyond traditional neurochecks to ensure timely identification of worsening conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Well Do Neurochecks Perform After Stroke? De Leon Benedetti, AM., Bhatia, R., Ancheta, SR., et al.[2021]

In a study of 8,936 ICU patients, it was found that hourly neurological assessments (neurochecks) were predominantly ordered by trauma, neurosurgery, and neurocritical care services, highlighting significant variations in practice patterns across different ICU services.

The median duration of hourly neurochecks was 1.09 days, with 19% of patients requiring them for over 3 days, indicating a need for standardized protocols to improve efficiency and patient outcomes in monitoring acute neurological injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practices and Patterns of Hourly Neurochecks: Analysis of 8,936 Patients With Neurological Injury. LaBuzetta, JN., Hirshman, BR., Malhotra, A., et al.[2022]

The study found that the adjusted 1-year incidence of recurrent traumatic brain injury (rTBI) was 4.48 per 100 person-years, which is lower than the crude estimate of 8.03 per 100 person-years, indicating that measurement errors in surveillance can significantly affect reported incidence rates.

Among various case definitions for identifying rTBI, the one based on radiological examinations was the most sensitive across all age groups, while specific definitions showed high accuracy in identifying cases, suggesting that improved surveillance methods can enhance understanding and prevention of rTBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent Traumatic Brain Injury Surveillance Using Administrative Health Data: A Bayesian Latent Class Analysis. Lasry, O., Dendukuri, N., Marcoux, J., et al.[2021]

The modified Simplified Motor Score (mSMS) effectively predicts adverse events in hospitalized adults with head injuries, but its predictive ability is not as strong as the Glasgow Coma Scale (GCS).

In a study of 64 patients, the GCS had an area under the curve (AUC) of 0.907, indicating high predictive accuracy for adverse outcomes, while the mSMS had an AUC of 0.796, showing it is a good but less reliable tool for assessing risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spanish versions of the Simplified Motor Score and the Glasgow Coma Scale in out-of-hospital treatment of head injury in adults: a preliminary study of each scale's ability to predict adverse events]. Roca, G., Mayol, S., García, E., et al.[2022]

The study analyzed 1,018 cases from the National Electronic Injury Surveillance System (NEISS) and found that mild traumatic brain injury (TBI) cases were more prevalent among infants under 1 year old, highlighting a vulnerable population that may require targeted interventions.

Using a broader definition for identifying TBI in NEISS significantly improved sensitivity from 38.9% to 79.6%, indicating that refining case definitions is crucial for better TBI detection and understanding in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case ascertainment in pediatric traumatic brain injury: challenges in using the NEISS. Xiang, H., Sinclair, SA., Yu, S., et al.[2019]

In a study of 1,448 patients with mild head injuries, 8.2% had abnormal CT scans, but only 0.76% required neurosurgery, indicating that while CT abnormalities are common, serious interventions are rare.

High-risk factors for detecting significant CT abnormalities included cranial soft-tissue injury, focal neurologic deficits, signs of basilar skull fracture, and age over 60, with a sensitivity of 91.6% for identifying patients needing further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of intracranial injury in patients with mild head trauma. Borczuk, P.[2022]

In a study of 124 TBI patients in the ICU, 71.8% underwent hourly neurological assessments for an average of 2.82 days, but prolonged assessments (over 4 days) were linked to a significantly longer hospital stay (23 days vs. 9 days).

While hourly checks are crucial in the acute phase for monitoring serious conditions, reducing the duration of these assessments for patients unlikely to need surgery may prevent unnecessary sleep deprivation and improve overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hourly neurologic assessments for traumatic brain injury in the ICU. Stone, JJ., Childs, S., Smith, LE., et al.[2015]

In a pilot study of 20 patients in the neurointensive care unit, 95% experienced neurological deterioration, with most events occurring within the first 24 hours, highlighting the high prevalence of such deterioration in this setting.

Despite frequent hourly neurological checks, 75% of patients developed delirium, suggesting that while these checks are important for acute monitoring, they may also contribute to sleep deprivation and worsen patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Deprivation in Neurointensive Care Unit Patients From Serial Neurological Checks: How Much Is Too Much? McLaughlin, DC., Hartjes, TM., Freeman, WD.[2018]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Reassessing hourly neurochecks. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Neurocheck Frequency: Determining Perceptions and Barriers to Implementation of Evidence-Based Practice. [2023]

3. Poland pubmed.ncbi.nlm.nih.gov

Analysis of the reliability of clinical examination in predicting traumatic cerebral lesions and skull fractures in patients with mild and moderate head trauma. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

How Well Do Neurochecks Perform After Stroke? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Practices and Patterns of Hourly Neurochecks: Analysis of 8,936 Patients With Neurological Injury. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Recurrent Traumatic Brain Injury Surveillance Using Administrative Health Data: A Bayesian Latent Class Analysis. [2021]

7. Spain pubmed.ncbi.nlm.nih.gov

[Spanish versions of the Simplified Motor Score and the Glasgow Coma Scale in out-of-hospital treatment of head injury in adults: a preliminary study of each scale's ability to predict adverse events]. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Case ascertainment in pediatric traumatic brain injury: challenges in using the NEISS. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Predictors of intracranial injury in patients with mild head trauma. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Hourly neurologic assessments for traumatic brain injury in the ICU. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Sleep Deprivation in Neurointensive Care Unit Patients From Serial Neurological Checks: How Much Is Too Much? [2018]