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Delirium Prevention in Patients From the Intensive Care Unit (DELA)

NCT03215745 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-10-27

No results posted yet for this study

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"

Conditions

  • Hypoactive Delirium
  • Hyperactive Delirium
  • Delirium of Mixed Origin

Interventions

BEHAVIORAL

Delirium prevention program

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.

Sponsors & Collaborators

  • Universidad de Santander

    lead OTHER

Principal Investigators

  • Claudia C Torres, RN, MSc · Universidad de Santander

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2018-07-01
Completion
2018-12-01

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215745 on ClinicalTrials.gov