Sleep Promotion in Critically Ill and Injured Patients Cared for in the Intensive Care Unit
NCT ID: NCT01082016
Last Updated: 2010-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2010-04-30
2013-06-30
Brief Summary
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Phase I (Development and Training): Develop an intervention manual for sleep promotion, Sleep Enhancement Program (SEP), and train ICU staff.
Phase II (Validation and Safety): Implement SEP and test for protocol fidelity and safety.
Phase III (Efficacy): Conduct a pilot trail to determine efficacy of SEP to improve SWS in ICU patients.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Control
Monitor sleep in ICU without attempts at promotion
No interventions assigned to this group
Sleep promotion
Measure sleep in ICU with sleep promotion program in effect
Sleep Enhancement Program (SEP)
Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients
Interventions
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Sleep Enhancement Program (SEP)
Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients
Eligibility Criteria
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Inclusion Criteria
* Received care in ICU no longer than 14 days
* Score of 3 to 5 on the Riker Sedation-Agitation Scale (SAS)
* Age \< 55 years
* Able to tolerate PO or have gastric access present (Nasogastric/Orogastric/PEG)
Exclusion Criteria
* Incarceration
* Admission diagnosis of Closed Head Injury or Traumatic Brain Injury
* Evidence of delirium on Confusion Assessment Method (CAM-ICU) Score
* Hemodynamic Instability
* Sepsis
* Multiple Organ Dysfunction
* Acute Renal Failure
* Known history of sleep disorder
* Known Psychiatric disorder
18 Years
55 Years
ALL
No
Sponsors
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Arizona Biomedical Research Commission (ABRC)
OTHER
University of Arizona
OTHER
Responsible Party
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University of Arizona College of Medicine
Principal Investigators
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Randall S Friese, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona College of Medicine
Locations
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University Medical Center
Tucson, Arizona, United States
Countries
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References
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Parthasarathy S, Friese RS, Ayas NT. Biological validity to sleep measurements during critical illness. Crit Care Med. 2010 Feb;38(2):705-6. doi: 10.1097/CCM.0b013e3181cbb05f. No abstract available.
Friese RS. Good night, sleep tight: the time is ripe for critical care providers to wake up and focus on sleep. Crit Care. 2008;12(3):146. doi: 10.1186/cc6884. Epub 2008 May 12.
Friese RS, Diaz-Arrastia R, McBride D, Frankel H, Gentilello LM. Quantity and quality of sleep in the surgical intensive care unit: are our patients sleeping? J Trauma. 2007 Dec;63(6):1210-4. doi: 10.1097/TA.0b013e31815b83d7.
Friese RS. Sleep and recovery from critical illness and injury: a review of theory, current practice, and future directions. Crit Care Med. 2008 Mar;36(3):697-705. doi: 10.1097/CCM.0B013E3181643F29.
Other Identifiers
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ABRC 9-022
Identifier Type: -
Identifier Source: org_study_id