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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.
Verified by University of California, San Francisco, February 2009
First Received: June 16, 2008   Last Updated: March 2, 2009   History of Changes
Sponsor: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00714194
  Purpose

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.


Condition Intervention Phase
Delirium
Sleep Perception
Procedure: Normal continuous sedation
Other: Daily interruption of continuous sedation
Phase 0

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: The Effect of Daily Interruption of Continuous Sedation on the Occurrence of Delirium and Perception of Sleep in ICU Patients

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Delirium and sleep [ Time Frame: 3 days in ICU ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: February 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Patients given the normal continuous sedation.
Procedure: Normal continuous sedation
Normal continuous sedation.
2: Experimental
Daily interruption of continuous IV sedatives between 7:00 am and 8:00 am.
Other: Daily interruption of continuous sedation
Withdrawal of normal continuous sedation with Lorazepam, Midazolam, and Propofol from 7:00 am to 8:00 am daily until continuous sedation discontinuation.

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., 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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714194

Contacts
Contact: Millie Figueroa, PhDc 787-240-9006 millie.figueroa@ucsf.edu

Locations
Puerto Rico
Trauma Unit University of Puerto Rico Medical Center Recruiting
San Juan, Puerto Rico
Contact: Millie Figueroa, PhDc     787-240-9006     millie.figueroa@ucsf.edu    
Principal Investigator: Millie Figueroa, RN, PHDc            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Chair: Geraldine V Padilla, PhD The Regents of the University of California, San Francisco
  More Information

No publications provided

Responsible Party: Department of Physiological Nursing, University of California San Francisco ( Geraldine Padilla, Professor and Associate Dean for Research )
Study ID Numbers: H41297-32404-01
Study First Received: June 16, 2008
Last Updated: March 2, 2009
ClinicalTrials.gov Identifier: NCT00714194     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
sedation
delirium
sleep
sedation withdrawal
ICU patients

Additional relevant MeSH terms:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Confusion
Neurobehavioral Manifestations
Delirium

ClinicalTrials.gov processed this record on November 25, 2009