Impact of Neurochecks on Sleep in Critically Ill Adults

Study Overview
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Brief Summary
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Background: Following acute brain injury (ABI), patients are monitored in the intensive care unit (ICU) where providers rely on frequent neurological examinations (neurochecks) to assess for neurodeterioration. Serial neurochecks are part of guideline recommendations, but there is equipoise between hourly (Q1) and every-other-hour (Q2) evaluation. In the ICU, care-related awakenings occur frequently, but it is unclear if differential neurocheck frequencies result in differential sleep, providing the scientific premise for this proposal. Population: Twenty-two patients (N=11 per group) who have undergone elective aneurysm coiling will be enrolled. On post-operative day (POD) 0, patients will be screened and approached for informed consent if they do not meet exclusion criteria, e.g., prior intracranial injury, sleep disorders, cognitive impairment, mechanical ventilation. Patients with elective aneurysm coiling are being chosen because they require ICU level of care following their intracranial procedure, but do not have structural brain injury or ongoing sedation needs that might impact sleep measurements. Methods: Usual care: Patients are monitored every 15-30 minutes for up to 6 hours post-procedure, then Q1 or Q2 for up to 24 hours. If these patients remain stable, they are discharged home on post-operative day (POD) 1. Proposed Intervention: Enrolled patients will be randomized to Q1 or Q2 neurochecks following the institutionally required 6 hours of stable neurological and vascular checks. Once randomized, patients will undergo placement of electroencephalogram (EEG) with video, electrooculogram, and chin lead. The video EEG will be in place for at least 8 hours to include the overnight (10PM-6AM) time period. Following completion of the recording, the signals obtained will be reviewed by a blinded polysomnographic sleep technician for sleep characteristics including quantitative assessments of wakefulness, deep (N3) sleep, REM sleep, sleep efficiency, and sleep fragmentation and arousals. On POD1, patients and their nurse will fill out the Richards-Campbell Sleep Questionnaire to rate subjective sleep quality.

Official Title
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Impact of Neurochecks on Sleep in Critically Ill Adults

Conditions
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Cerebral Aneurysm

Intervention / Treatment
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* Behavioral: Neurocheck frequency


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a. Adult patients age >18 years who are status post uncomplicated elective coiling of unruptured cerebral aneurysm. Exclusion Criteria: Patients with past or current intracranial injury or disease. Patients with known flow-limiting pathology of carotid arteries, vertebral arteries, or intracranial arteries. Incomplete resolution of aneurysm. Known sleep disorders (e.g., insomnia) Pregnancy. Incarceration. Inability to communicate in English Cognitive impairment or lack of decision-making capacity. Ongoing sedation. Mechanical ventilation

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hourly Neurochecks<br>Patients awakened for neurological exams every hour | Behavioral: Neurocheck frequency<br>* Randomized to hourly or every-other-hour examinations<br>|
| Active Comparator: Every-Other-Hour Neurochecks<br>Patients awakened for neurological exams every-other-hour | Behavioral: Neurocheck frequency<br>* Randomized to hourly or every-other-hour examinations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | Ratio of total sleep time compared to time in bed, reported as a percentage | Within 24 hours of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wakefulness | Blinded quantitative assessment of time spent awake | Within 24 hour of enrollment | 
| REM Sleep | Blinded quantitative assessment of time spent in REM sleep | Within 24 hour of enrollment | 
| Deep Sleep | Blinded quantitative assessment of time spent in deep sleep | Within 24 hour of enrollment | 
| Arousals | Blinded quantitative assessment of number of arousals (as defined by American Academy of Sleep Medicine) | Within 24 hour of enrollment | 
| Sleep quality (subjective) | As measured by Richards Campbell Sleep Questionnaire | Within 24 hour of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurocheck; sleep; neurological examination