- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00714194
Effect of Daily Interruption of Continuous Sedation on Delirium, Sleep Perception in Intensive Care Unit (ICU) Patients (ICUDelirium)
The Effect of Daily Interruption of Continuous Sedation on the Occurrence of Delirium and Perception of Sleep in ICU Patients
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
-
San Juan, Puerto Rico
- Trauma Unit University of Puerto Rico Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
Normal continuous sedation.
|
Experimental: 2
Patients in the intervention group will receive daily interruption of sedative.
|
Withdrawal of normal continuous sedation with Lorazepam, Midazolam, and Propofol from 7:00 am to 8:00 am daily until continuous sedation discontinuation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Delirium and sleep
Time Frame: 3 days in ICU
|
3 days in ICU
|
Collaborators and Investigators
Investigators
- Study Chair: Geraldine V Padilla, PhD, The Regents of the University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H41297-32404-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Delirium
-
Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
-
Imperial College Healthcare NHS TrustRecruitingCardiac Surgery | Intensive Care Unit Delirium | Post Operative DeliriumUnited Kingdom
-
Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicRecruitingDelirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional StateNorway
-
Menoufia UniversityCompleted
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingDelirium | Delirium on Emergence | Hearing Loss | Hearing Loss, High-Frequency | Hearing Loss, Sensorineural | Delirium, Cause Unknown | Hearing Loss, Bilateral | Hearing Disability | Delirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional State | Delirium With... and other conditionsUnited States
-
Universidad de SantanderUnknownDelirium of Mixed Origin | Hypoactive Delirium | Hyperactive DeliriumColombia
-
Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
-
Charite University, Berlin, GermanyBARMERRecruitingDelirium in Old AgeGermany
-
Mayo ClinicCompletedPost-Operative DeliriumUnited States
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland
Clinical Trials on Normal continuous sedation
-
Palle ToftUniversity of Southern Denmark; Sygehus Lillebaelt; The Danish Council for Strategic...CompletedMuscular Atrophy | Critically IllDenmark
-
Spectrum Health HospitalsHelen DeVos Children's HospitalCompletedEncephalopathy | Developmental Delay and Behavioral Changes | Cord Tumor Compression or Instability | Cord Tethering or MalformationUnited States
-
University of California, San DiegoCompletedBreast Cancer | Mastectomy | Paravertebral Catheter InsertionUnited States
-
Memorial Medical CenterTerminatedRespiratory InsufficiencyUnited States
-
Virginia Commonwealth UniversityNational Institutes of Health (NIH); American Lung AssociationTerminatedDepression | Quality of Life | Sedation | Post-traumatic Stress Disorder | Mechanical Ventilation
-
Poitiers University HospitalCompletedFracture | Dislocation | Reality Device | Reduction ProcedureFrance
-
Shandong UniversityWeihai Municipal Hospital; Qilu Hospital of Shandong University (Qingdao); Binzhou...UnknownEarly Detection of CancerChina
-
University of EdinburghGE Healthcare; Chief Scientist Office of the Scottish GovernmentCompletedCritical IllnessUnited Kingdom
-
Englewood Hospital and Medical CenterTerminated
-
Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting