Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05864300
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2023-05-01
Brief Title:
Impact of Neurochecks on Sleep in Critically Ill Adults
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Impact of Neurochecks on Sleep in Critically Ill Adults
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 N15 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 eg 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
Population Thirty patients N15 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 eg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None