120 Participants Needed

Neurochecks for Brain Injury

JN
Overseen ByJamie N LaBuzetta
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.23467

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
See 1 more

Exclusion Criteria

Pregnancy
I have unstable bleeding in my brain.
I have had a brain injury in the past.
See 7 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Every-Other-Hour NeurochecksExperimental Treatment1 Intervention
Group II: Hourly NeurochecksActive Control1 Intervention

Find a Clinic Near You

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

Citations

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 ...
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 ...
Neurochecks for Brain InjuryA survey of 177 healthcare providers revealed that both ordering and performing providers preferred every-other-hour neurochecks for patients with acute brain ...
Reassessing Hourly Neurochecks - PMCIn patients with traumatic brain injury (TBI), individuals examined hourly required very few interventions after 48 hours had elapsed, yet those monitored ...
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- ...
Practices and Patterns of Hourly Neurochecks - PubMed CentralPatients experiencing acute neurological injury often receive hourly neurological assessments (“neurochecks”) to capture signs of deterioration.
Short-term And Longer-term Cognitive Impact Of NeurochecksThis project will randomize patients with acute spontaneous. Second, longer-term cognitive outcomes will be investigated in patients with ICH randomized to Q1 ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security