Delirium Prevention in Patients From the Intensive Care Unit (DELA) (DELA)
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ClinicalTrials.gov Identifier: NCT03215745 |
Recruitment Status : Unknown
Verified October 2017 by Universidad de Santander.
Recruitment status was: Recruiting
First Posted : July 12, 2017
Last Update Posted : October 27, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hypoactive Delirium Hyperactive Delirium Delirium of Mixed Origin | Behavioral: Delirium prevention program | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Trial Randomized, Double-blind, Controlled of Delirium Prevention Program in Patients From the Intensive Care Unit Los Comuneros Hospital University of Bucaramanga, Colombia |
Actual Study Start Date : | October 1, 2017 |
Estimated Primary Completion Date : | July 1, 2018 |
Estimated Study Completion Date : | December 1, 2018 |
Arm | Intervention/treatment |
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Experimental: Delirium prevention program
Delirium 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.
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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. |
No Intervention: Control group
Usual care
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- Delirium [ Time Frame: Within the first 30 days after admission at ICW ]For the measurement of delirium will be with the instrument Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) version in spanish.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215745
Contact: Claudia C Torres, RN, MSc | 57-7-6516500 ext 1221 | claudiaconsuelo@yahoo.com | |
Contact: Astrid N Páez, RN, MSc | 57-7-6516500 ext 1221 | nathaliapaez1@hotmail.com |
Colombia | |
Los Comuneros Hospital University of Bucaramanga | Recruiting |
Bucaramanga, Santander, Colombia, 68006 | |
Contact: Claudia C Torres, MSc 57-6516500 ext 1221 claudiaconsuelo@yahoo.com | |
Contact: Astrid N Páez, Msc 57-6516500 ext 1221 nathaliapaez1@hotmail.com |
Principal Investigator: | Claudia C Torres, RN, MSc | Universidad de Santander |
Responsible Party: | Universidad de Santander |
ClinicalTrials.gov Identifier: | NCT03215745 |
Other Study ID Numbers: |
012-2014 |
First Posted: | July 12, 2017 Key Record Dates |
Last Update Posted: | October 27, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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