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| Tracking Information | |||||
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| First Received Date ICMJE | June 16, 2008 | ||||
| Last Updated Date | March 2, 2009 | ||||
| Start Date ICMJE | February 2009 | ||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Delirium and sleep [ Time Frame: 3 days in ICU ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00714194 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Daily Interruption of Continuous Sedation on Delirium, Sleep Perception in Intensive Care Unit (ICU) Patients | ||||
| Official Title ICMJE | The Effect of Daily Interruption of Continuous Sedation on the Occurrence of Delirium and Perception of Sleep in ICU Patients | ||||
| Brief 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. |
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| 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). |
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| Study Phase | Phase 0 | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 250 | ||||
| Estimated Completion Date | June 2009 | ||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Puerto Rico | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00714194 | ||||
| Responsible Party | Geraldine Padilla, Professor and Associate Dean for Research, Department of Physiological Nursing, University of California San Francisco | ||||
| Study ID Numbers ICMJE | H41297-32404-01 | ||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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