Nursing Intervention to Reduce Incidence and Duration of Delirium in Patients in Intensive Care

NCT05172583 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2021-12-29

No results posted yet for this study

Summary

Introduction: Delirium is a cognitive alteration of acute onset and fluctuating course, characterized by the reduced capacity to pay attention to the environment, memory impairment, disorientation, language, and perception alteration. Its incidence varies between 20 and 90% in ICU patients. It shows high variability in both incidence and typology, representing a phenomenon of great interest to nursing, who can make timely interventions.

General objective: To determine the effectiveness of nursing interventions based on the Dynamic Symptoms Model and scientific evidence, compared to daily care, for reducing the incidence and duration of delirium in people hospitalized in the adult ICU.

Methodology: Study with a quantitative approach, experimental design of the type Randomized Controlled Clinical Trial of parallel groups, phase III in which the effectiveness and safety of the intervention designed in a particular population are evaluated, such as the ICU population, who are older risk of developing delirium. The sample will be 71 people for the intervention group and 142 for the control group, with a 2: 1 ratio.

Expected outcome: The primary results are: reduce the incidence and duration of delirium in ICU patients, and the secondary outcomes are: shorter ICU stay, mechanical ventilation, use of physical restraints, less pain intensity, and more days in RASS between -2 and + 1.

Risk: Greater than the minimum.

Conditions

  • Delirium

Interventions

BEHAVIORAL

Control

The control groups will receive the nursing interventions that are performed daily in the adult ICU. These are orientation in time, space, and place, accompaniment of the family for two hours in the morning and two hours in the afternoon, physical therapy once a day according to the patient's condition, medication with conscious sedation, and progressive reduction analgesics. opioids and benzodiazepines.

BEHAVIORAL

Interventions to reduce delirium based on DSM and scientific evidence

The interventions are designed from the structure of the Dynamic Symptoms Model (DSM), taking into account the antecedents of delirium, physiological such as the medical condition of mechanical ventilation and pain, and drug treatment with sedatives and analgesics; the psychological, social, and spiritual antecedents with stimulation in the values, life experience, personality and spirituality, and the environmental antecedents with an adaptation of the physical conditions of the ICU. In addition, previous experience with identification and care of concomitant symptoms such as fear, confusion, restlessness, loneliness, and discomfort, and with the measurement and classification of the trajectory of delirium when it occurs, will also be considered. The interventions follow the scientific evidence, mainly from the ABCDEF bundle. All interventions are non-pharmacological.

Sponsors & Collaborators

  • Universidad Nacional de Colombia

    collaborator OTHER
  • Universidad Surcolombiana

    lead OTHER

Principal Investigators

  • Ángela M Henao Castaño, PhD · Universidad Nacional de Colombia

  • Dolly O Arias Torres, PhD · Universidad Surcolombiana

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2022-01-31
Completion
2022-03-31

Countries

  • Colombia

Study Locations

More Related Trials

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 NCT05172583 on ClinicalTrials.gov