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| 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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effect of Daily Interruption of Continuous Sedation on the Occurrence of Delirium and Perception of Sleep in ICU Patients |
| Estimated Enrollment: | 250 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Patients in the control group will receive continuous sedative infusions without daily interruption of sedatives based on the standard clinical practice of the TICU.
|
Procedure: Normal continuous sedation
Normal continuous sedation.
|
|
Experimental: 2
Patients in the intervention group will receive daily interruption of sedative.
|
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.
Other Name: Ativan®, Versed®, Driprivan®
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Puerto Rico | |
| Trauma Unit University of Puerto Rico Medical Center | |
| San Juan, Puerto Rico | |
| Study Chair: | Geraldine V Padilla, PhD | The Regents of the University of California, San Francisco |
More Information
| Responsible Party: | Geraldine Padilla, Professor and Associate Dean for Research, Department of Physiological Nursing, University of California San Francisco |
| ClinicalTrials.gov Identifier: | NCT00714194 History of Changes |
| Other Study ID Numbers: | H41297-32404-01 |
| Study First Received: | June 16, 2008 |
| Last Updated: | January 15, 2010 |
| Health Authority: | United States: Institutional Review Board |
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sedation delirium sleep sedation withdrawal ICU patients |
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Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
