Effect of Daily Interruption of Continuous Sedation on Delirium, Sleep Perception in Intensive Care Unit (ICU) Patients
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Delirium; Sleep Perception
Intervention: Normal continuous sedation (Procedure); Daily interruption of continuous sedation (Other)
Phase: N/A
Status: Recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Geraldine V Padilla, PhD, Study Chair, Affiliation: The Regents of the University of California, San Francisco
Overall contact:
Millie Figueroa, PhDc, Phone: 787-240-9600, Email: millie.figueroa@ucsf.edu
Summary
This is an intervention study whose purpose is to determine whether daily interruption of
sedative infusion contributes to the reduction of the occurrence of delirium and improves
sleep perception in critically ill patients. Patients in a trauma intensive care unit (TICU)
receiving mechanical ventilation and continuous infusion of sedatives will be enrolled in the
study. A patient will be entered into the study after the family member has consented to have
the patient participate.
Clinical Details
Official title: The Effect of Daily Interruption of Continuous Sedation on the Occurrence of Delirium and Perception of Sleep in ICU Patients
Study design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Delirium and sleep
Detailed description:
This is an intervention study whose purpose is to determine whether daily interruption of
sedative infusion contributes to the reduction of the occurrence of delirium and improves
sleep perception in critically ill patients. Patients in a trauma intensive care unit (TICU)
receiving mechanical ventilation and continuous infusion of sedatives will be enrolled in the
study. A patient will be entered into the study after the family member has consented to have
the patient participate. A sequential assignment method will be used to compare two groups of
20 patients in each group. The first group of 20 patients (control group [CG]) to be studied
will receive continuous sedative infusion without daily interruption. The second group of 20
patients (intervention group [IG]) will receive a daily interruption of sedative infusion.
If control and intervention group data are not sufficient to elicit the effect of daily
interruption of sedatives, data collection will continue using the sequential assignment
method alternating control and intervention group 10 patients at a time. This method will
proceed until an effect is detected or until the a priori sample size of 182 (i. e., 91
patients per group) has been reached.
The intervention group will be monitored during the daily interruption of sedative infusion
(i. e., wake-up time, Sedation Wake-up Protocol) in order to measure the following variables:
delirium, physiological response (heart rate [HR], respiratory rate [RR], blood pressure
[BP], and pulse oxygen saturation [SpO2]), pain intensity, and agitation/sedation level.
Delirium will be measured 3 times a day for a maximum of 3 days in both groups after
continuous deep sedation discontinuation using the Confusion Assessment Method for the
Intensive Care Unit (CAM-ICU). Sleep perception will be measured by a sleep questionnaire
(Sleep Perception in the ICU) after discontinuous of continuous sedation. Agitation/sedation
level will be measured with the Richmond Agitation-Sedation Scale (RASS) and Bispectral Index
(BIS), and pain intensity with a 0 to 10 numeric rating scale (NRS).
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients ≥ 21 years will be recruited from a Trauma Intensive Care Unit of Puerto
Rico. This unit receives critically ill patients with three or more affected body
systems involved after motor vehicle accident, gunshot injury, penetrating injury, and
falls.
Exclusion Criteria:
- Baseline neurological diseases
- Head trauma or acute neurological injury with Glasgow Coma Scale score < 8
- Death expected within 24 hours (APACHE II ≥ 30)
- History of alcoholism
- History of drug dependence
- Deaf and blind patients
Locations and Contacts
Millie Figueroa, PhDc, Phone: 787-240-9600, Email: millie.figueroa@ucsf.edu
Trauma Unit University of Puerto Rico Medical Center, San Juan, Puerto Rico; Recruiting
Millie Figueroa, PhDc, Phone: 787-240-9600, Email: millie.figueroa@ucsf.edu
Millie Figueroa, RN, PHDc, Principal Investigator
Additional Information
Starting date: August 2008
Ending date: June 2009
Last updated: August 7, 2008
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