Delirium Prevention in Patients From the Intensive Care Unit (DELA)
DELA
Trial Randomized, Double-blind, Controlled of Delirium Prevention Program in Patients From the Intensive Care Unit Los Comuneros Hospital University of Bucaramanga, Colombia
1 other identifier
interventional
200
1 country
1
Brief Summary
"To determine the efficacy of program of prevention of delirium in critically ill patients from the intensive care units of Bucaramanga and Floridablanca. Methods: The study will be a randomized controlled clinical trial in 600 critically ill patients recruited at 24 hours from arrival on the intensive care units of Bucaramanga and Floridablanca, without delirium, with ≥50% in the PREDELIRIC scale score, who comply with the inclusion and exclusion. The patients will be randomized in blocks to one of the two groups, intervention group (delirium prevention program, n=200) with control group (usual care; n= 400), the study will compare the incidence of delirium in both groups. Patients will be followed every day with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) until the patient presents delirium, exit to hospitalization or death. Delirium prevention program includes individualized nonpharmacological interventions such as multisensory stimulation, cognitive stimulation, activate the functional and family involvement. The study has received ethical approval from the University of Santander"
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2017
CompletedFirst Posted
Study publicly available on registry
July 12, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 27, 2017
October 1, 2017
9 months
July 10, 2017
October 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delirium
For the measurement of delirium will be with the instrument Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) version in spanish.
Within the first 30 days after admission at ICW
Study Arms (2)
Delirium prevention program
EXPERIMENTALDelirium prevention program involved a non-pharmacologic preventive interventions that will be focused in: Delirium prevention program includes individualized non-pharmacological interventions such as multisensory stimulation, cognitive stimulation, activate the functional and family involvement.
Control group
NO INTERVENTIONUsual care
Interventions
Delirium prevention program Placard with the names of the care team and the calendar days; cognitively stimulating activities three times a day. Pictures, radio, robe. Visual aids large print books, with daily reinforcement of use Maintain adequate lighting opening blinds and curtains during the day, and darken their environment at night. Dissipation wax and special techniques of communication, with daily reinforcement of these adaptations. Go to the patient by name and tone of voice appropriate. Always listen. Use simple and clear language, face-to-face. Avoid excessive familiarity and childish. Promote family involvement in self-care and caregivers and the reorientation of the patient, contact with extended family during the stay.
Eligibility Criteria
You may qualify if:
- Be older than 18 years
- To have 24 hours of stay from the ingress to the intensive care unit
- To expire with the criteria of intensive care unit defined by the investigative group (it presents itself with support, with invasive mechanical ventilation.
- Patient without delirium in the revenue
- Patients who present a percentage of prediction bigger than 50% according to the model PREDELIRIC
You may not qualify if:
- Patients who scale of sedation RASS is applied and have like result of +4 and +5( scale that is applied systematically to the patient in intensive care unit)
- Subjects with cognitive deficit or previous mental illness
- Patients with precedents previous to delirium or in which the delirium measurement could be affected by its base condition
- Patients with alcoholism precedents.
- To be at the moment of the application of the instruments under substances that limit its skill to communicate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Los Comuneros Hospital University of Bucaramanga
Bucaramanga, Santander Department, 68006, Colombia
Related Publications (1)
Contreras CCT, Esteban ANP, Parra MD, Romero MKR, Silva CGD, Buitrago NPD. Multicomponent nursing program to prevent delirium in critically ill patients: a randomized clinical trial. Rev Gaucha Enferm. 2021 Nov 3;42:e20200278. doi: 10.1590/1983-1447.2021.20200278. eCollection 2021. English, Spanish.
PMID: 34755800DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia C Torres, RN, MSc
Universidad de Santander
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2017
First Posted
July 12, 2017
Study Start
October 1, 2017
Primary Completion
July 1, 2018
Study Completion
December 1, 2018
Last Updated
October 27, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share