Critical Illness Clinical Trial
Official title:
Effect of Sleep on the Recovery of Patients Admitted to the ICU
Verified date | June 2023 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators plan to create several sleep/circadian rhythm friendly rooms within the medical intensive care unit to determine if decreasing sleep fragmentation effects recovery in patients hospitalized in the ICU.
Status | Completed |
Enrollment | 51 |
Est. completion date | January 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - any adult patient admitted to the MICU with an expected length of stay of at least 3 days Exclusion Criteria: - frequent overnight neurological checks or frequent peripheral vascular checks |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of Stay in ICU | Time spent from admission to ICU until transfer/discharge or study cessation | through study completion, an average of 3-4 days | |
Primary | Overall Hospital Length of Stay | Total time spent from admission to ICU until discharge from hospital | at study completion, an average of 5-7 days | |
Primary | Rate of ICU mortality | rate of mortality while admitted to ICU | at study completion, up to 30 days | |
Primary | Rate of Delirium | Assess development of delirium through administration of CAM-ICU and RASS performed daily by nursing staff per routine care. Delirium will be considered present if CAM-ICU is positive or RASS above +1 or below -1 at anytime during study. | Once daily throughout study, on average 3-4 days | |
Primary | Hospital Readmission Rate | rate of hospital readmission within 30-days of discharge | 30 days after discharge | |
Secondary | ICU sleep score | Assess sleep quality through administration of Richard Campbell Sleep Questionnaire (RCSQ). RCSQ is a simple and validated survey to measure sleep quality in ICU settings. RCSQ consists of a series of 8 patient reported questions covering sleep depth, sleep latency, total amount of sleep, number of awakenings, sleep quality, noise rating, light rating, and sleep quality compared to at home. All questions are to be reported on a scale of 0-100 with higher values corresponding to better sleep values. | daily through study completion, an average of 3-4 days | |
Secondary | Overnight Sound Intensity Levels | sound intensity (decibel) within patient room with be continuously recorded through SDL-600 industrial decibel monitors. | through study completion, an average of 3-4 days | |
Secondary | Overnight Light Intensity Exposure | amount of light patients are exposed to overnight, measured in lux, will be continuously recorded through specialized medical lux monitors. | through study completion, an average of 3-4 days | |
Secondary | Concentration of Interleukin-6 (IL-6) and interleukin-10 (IL-10) | concentrations of IL-6 (pg/mL) and IL-10 (pg/mL), inflammatory cytokines found to play a role in circadian regulation, levels will be measured from approximately 2mL of plasma that will be collected concurrently during morning routine care lab draw. | Study Day 1 and Day 2 | |
Secondary | Concentration of 6-sulphatoxymelatonin (aMT6s) | concentrations of 6-sulphatoxymelatonin (pg/mL), the primary urine metabolite of melatonin and circadian rhythm phase marker, will be measured from left-over voided urine collected from patients prior to discard. | Study Day 1 and Day 2 | |
Secondary | Concentration of Lipopolysaccharide binding protein (LBP) | Levels of LBP (pg/mL), an acute phase protein that upregulates during an inflammatory physiologic state, will be measured from 2mL of blood taken concurrently with routine morning labs. | Study Day 1 and Day 2 |
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