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Effect of Daily Interruption of Continuous Sedation on Delirium, Sleep Perception in Intensive Care Unit (ICU) Patients (ICUDelirium)
This study is currently recruiting participants.
Study NCT00714194   Information provided by University of California, San Francisco
First Received: June 16, 2008   Last Updated: March 2, 2009   History of Changes

June 16, 2008
March 2, 2009
February 2009
June 2009   (final data collection date for primary outcome measure)
Delirium and sleep [ Time Frame: 3 days in ICU ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00714194 on ClinicalTrials.gov Archive Site
 
 
 
Effect of Daily Interruption of Continuous Sedation on Delirium, Sleep Perception in Intensive Care Unit (ICU) Patients
The Effect of Daily Interruption of Continuous Sedation on the Occurrence of Delirium and Perception of Sleep in ICU Patients

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.

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., sedation wake-up trial[SWT])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.Once the patient is awake during the SWT period, the patient will be screened for SBT. If the patient meets the SBT criteria, then the mechanical ventilator mode will be changed to continuous positive airway pressure (CPAP) or the patient will be placed in a T-tube circuit for 2 hours or until the patient presents signs of SBT failure. 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).

Phase 0
Interventional
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
  • Delirium
  • Sleep Perception
  • Procedure: Normal continuous sedation
  • Other: Daily interruption of continuous sedation
  • No Intervention: Patients given the normal continuous sedation.
  • Experimental: Daily interruption of continuous IV sedatives between 7:00 am and 8:00 am.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
250
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Millie Figueroa, PhDc 787-240-9006 millie.figueroa@ucsf.edu
Puerto Rico
 
NCT00714194
Geraldine Padilla, Professor and Associate Dean for Research, Department of Physiological Nursing, University of California San Francisco
H41297-32404-01
University of California, San Francisco
 
Study Chair: Geraldine V Padilla, PhD The Regents of the University of California, San Francisco
University of California, San Francisco
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP