Critical Illness Clinical Trial
Official title:
Improving the Sleep and Circadian Rhythms of Mechanically Ventilated Patients
Verified date | May 2018 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 years or older - Receiving mechanical ventilation and intravenous sedation Exclusion Criteria: - Debilitating central nervous system disease or degenerative disorder - Active seizures - Persistent coma - Renal failure requiring dialysis - Expected to be extubated within 24 hours - Currently receiving neuromuscular blocker |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Brian Gehlbach | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Circadian Timing | The magnitude of the phase change in 6-sulfatoxymelatonin excretion between Day 1 and Day 3 will be compared between the intervention and usual care groups. This is done by comparing, for each group, the timing of the best-fit maximum on Day 1 with the timing of the best-fit maximum on Day 3. The result is expressed in hours. A positive value represents a phase advance from Day 1 to Day 3 (e.g. an earlier occurrence of maximum excretion on Day 3 when compared with Day 1), while a negative value represents a phase delay from Day 1 to Day 3 (e.g. a later occurrence of maximum excretion on Day 3 when compared with Day 1). | Day 1 to Day 3 | |
Secondary | Normal Circadian Timing | The percentage of subjects who exhibit normal circadian timing of 6-sulfatoxymelatonin excretion on Day 3 will be compared between the intervention and usual care groups. | Day 3 | |
Secondary | Circadian Amplitude | The amplitude (e.g. one half the value from peak to trough of the fitted cosine curve) of the circadian rhythm of 6-sulfatoxymelatonin on Day 3 will be compared between the usual care and intervention groups. | Day 3 | |
Secondary | Spectral Edge Frequency 95% | The difference between the polysomnographically derived daytime and nocturnal spectral edge frequency 95% parameter will be used as a measure of increased diurnal sleep/wake activity. This parameter will be compared between the usual care and intervention groups. | Day 2 | |
Secondary | Delirium | The percentage of patients who are delirious at the conclusion at the study will be compared between the intervention and usual care groups. | Day 3 |
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