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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the frequency of doctor checks for brain injury patients in the ICU affects their sleep and mental health. The researchers aim to determine if frequent waking for these checks might increase confusion or even lead to dementia later. Patients with a type of brain bleed, known as intracerebral hemorrhage, who are stable in the ICU may qualify. The trial will compare patients checked every hour with those checked every other hour. As an unphased trial, it offers patients the opportunity to contribute to important research that could enhance ICU care practices.

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 prior data suggests that this neurocheck frequency protocol is safe for older patients with acute brain injury?

Research has shown that regular neurochecks, frequent neurological exams, are common for people with brain injuries. These exams help detect any decline in brain function. One study found that patients with traumatic brain injuries often underwent checks every hour but required fewer interventions after 48 hours. This suggests that such frequent checks might not always be necessary.

Another study examined 227 people with mild to moderate head injuries. It found that abnormal neurological exams were crucial for identifying brain injuries. However, the study did not address how often these exams should occur.

This trial examines the frequency of neurochecks, so there isn't direct data comparing the safety of hourly checks versus checks every other hour. However, since both methods are standard practices, they are generally considered safe. The trial is in the "Not Applicable" phase, focusing on understanding effects rather than proving safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Neurochecks for Brain Injury" trial because it explores how the frequency of neurological examinations might impact patient outcomes after brain injuries. Unlike the traditional approach of conducting hourly neurochecks, this trial introduces a new method where patients are checked every other hour. This could potentially reduce patient discomfort and sleep disruption without compromising safety or effectiveness. By comparing these two strategies, the trial aims to find a balance that maintains patient care quality while improving comfort and recovery.

What evidence suggests that this trial's neurocheck frequencies could be effective for managing delirium in patients with acute brain injury?

This trial will compare two different frequencies of neurochecks for patients with brain injuries. Research has shown that checking patients' brain function every other hour might lower the risk of confusion in those with serious brain injuries. A survey of healthcare workers found they prefer this less frequent monitoring because it might be safer and disturb patients' sleep less. In this trial, one group will receive hourly neurochecks, while another group will receive neurochecks every other hour. For patients with traumatic brain injuries, those checked every hour often needed fewer treatments after the first two days. This suggests that checking less often could still keep patients safe while allowing them more rest. Therefore, every-other-hour checks could be a helpful way to support recovery from brain injuries. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Any patient included in part 1 alive at 6 months post-discharge

Exclusion Criteria

Pregnancy

I have unstable bleeding in my brain.

I have had a brain injury in the past.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9931930/

Neurocheck Frequency: Determining Perceptions and ...

Following acute brain injury (ABI), patients in the intensive care unit (ICU) often undergo hourly or every-other-hour exams (“neurochecks”) to monitor for ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06219889

Study Details | NCT06219889 | Short-term And Longer- ...

This project will randomize patients with acute spontaneous intracerebral hemorrhage (ICH) to either hourly (Q1) or every-other-hour (Q2) neurochecks and ...

3.

withpower.com

withpower.com/trial/phase-hemorrhage-2024-874ac

Neurochecks for Brain Injury

A survey of 177 healthcare providers revealed that both ordering and performing providers preferred every-other-hour neurochecks for patients with acute brain ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10023484/

Reassessing Hourly Neurochecks - PMC

In patients with traumatic brain injury (TBI), individuals examined hourly required very few interventions after 48 hours had elapsed, yet those monitored ...

5.

researchgate.net

researchgate.net/publication/362787462_Neurocheck_Frequency_Determining_Perceptions_and_Barriers_to_Implementation_of_Evidence-Based_Practice

Neurocheck Frequency: Determining Perceptions and ...

The survey response rate was 58% among physicians and 51% among bedside nurses with neurological expertise. The most common medical and non- ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8727647/

Practices and Patterns of Hourly Neurochecks - PubMed Central

Patients experiencing acute neurological injury often receive hourly neurological assessments (“neurochecks”) to capture signs of deterioration.

7.

clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/trial/NCT06219889

Short-term And Longer-term Cognitive Impact Of Neurochecks

This project will randomize patients with acute spontaneous. Second, longer-term cognitive outcomes will be investigated in patients with ICH randomized to Q1 ...