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Effects of Implementation of a new Pain, Agitation, and Delirium guideline in the Intensive Care Unit.


- candidate number20919
- NTR NumberNTR4902
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-nov-2014
- Secondary IDsMETC nr: 14-N-99 
- Public TitleEffects of Implementation of a new Pain, Agitation, and Delirium guideline in the Intensive Care Unit.
- Scientific TitlePrevention of Delirium in the Intensive Care Unit (ICU)
- ACRONYM
- hypothesisRecently, The American College of Critical Care Medicine provided new guidelines for treating pain, agitation, and delirium in the ICU, in which detection and standardized treatment of pain are important issues. By implementing these new guidelines in our Intensive Care Unit, we expect a reduction in the incidence of pain, and possibly also a decreased incidence of delirium. We present the following research question: Does the implementation of pain measurement instruments and standardized treatment of pain, improve the prognosis of patients in the ICU of the Atrium Medisch Centrum Parkstad, and will that lead to a decrease in the incidence of delirium?
- Healt Condition(s) or Problem(s) studiedDelirium, Prevention, Intensive care, Pain
- Inclusion criteriaAll patients admitted to the Intensive Care Unit of the Atrium Medisch Centrum Parkstad between November 2014 and February 2015 are treated according to latest Pain, Agitation, and Delirium guideline.
- Exclusion criteria-Age < 18 years
-Pre-existent delirium 24 hours before admittance to ICU
-Richmond Agitation Sedation Score (RASS) -4/-5 during ICU stay
-< 24 hours ICU stay
-Deafness or serious visual impairment
-Unable to speak or understand Dutch language
-Serious mental handicaps
-Pre-existent cognitive impairment or dementia
-Aphasia
-Delirium screening compliance rate <80% during ICU stay
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 17-nov-2014
- planned closingdate9-feb-2015
- Target number of participants100
- InterventionsAll ICU patients included in the study will be treated according to the new pain, agitation, and delirium guideline during 12 weeks (group A). Primary and secondary outcomes will be registered. Data will be compared with earlier results of patients in the ICU receiving care as usual (group B).
- Primary outcomeDelirium incidence
- Secondary outcomeICU stay, hospital stay, mortality, comorbidity, NRS/CPOT score, RASS score, CAM-ICU score.
- TimepointsPain detection: Numeric Rating Scale (NRS) or Critical Care Observation Score (CPOT) : 3x/day.
Monitoring depth of sedation: Richmond Agitation-Sedation Scale (RASS): 3x/day.
Detecting delirium: Confusion Assessment Method for the ICU (CAM-ICU): 3x/day.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. H.J.H. Bremer
- CONTACT for SCIENTIFIC QUERIESDrs. M.C.E. Woude, van der
- Sponsor/Initiator Atrium Medisch Centrum Parkstad
- Funding
(Source(s) of Monetary or Material Support)
Atrium Medisch Centrum Parkstad
- PublicationsNone.
- Brief summaryRecently, The American College of Critical Care Medicine provided new guidelines for treating pain, agitation, and delirium in the ICU, in which detection and standardized treatment of pain are important issues. By implementing these new guidelines in our ICU, we expect an improved prognosis of patients and possibly a decrease in the incidence of delirium.
- Main changes (audit trail)
- RECORD13-nov-2014 - 22-dec-2014


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