Impact of Neurochecks on Sleep in Critically Ill Adults
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: Thirty patients (N=15 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92130
- UC San Diego Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
a. Adult patients 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Hourly Neurochecks
Patients awakened for neurological exams every hour
|
Randomized to hourly or every-other-hour examinations
|
|
Active Comparator: Every-Other-Hour Neurochecks
Patients awakened for neurological exams every-other-hour
|
Randomized to hourly or every-other-hour examinations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep efficiency
Time Frame: Within 24 hours of enrollment
|
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
Time Frame: Within 24 hour of enrollment
|
Blinded quantitative assessment of time spent awake
|
Within 24 hour of enrollment
|
|
REM Sleep
Time Frame: Within 24 hour of enrollment
|
Blinded quantitative assessment of time spent in REM sleep
|
Within 24 hour of enrollment
|
|
Deep Sleep
Time Frame: Within 24 hour of enrollment
|
Blinded quantitative assessment of time spent in deep sleep
|
Within 24 hour of enrollment
|
|
Arousals
Time Frame: Within 24 hour of enrollment
|
Blinded quantitative assessment of number of arousals (as defined by American Academy of Sleep Medicine)
|
Within 24 hour of enrollment
|
|
Sleep quality (subjective)
Time Frame: Within 24 hour of enrollment
|
As measured by Richards Campbell Sleep Questionnaire
|
Within 24 hour of enrollment
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCSD IRB: #806351
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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