Nursing Intervention to Reduce Incidence and Duration of Delirium in Patients in Intensive Care
试验速览
- 阶段
- 不适用
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Changes in cognitive state, presence or absence of delirium with Confusion Assessment Method for the Intensive Care Unit CAM-ICU scale
研究概览
简要总结
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.
详细描述
Framework Delirium epidemiology
Delirium is a cognitive alteration, with an acute onset and fluctuating course, characterized by a reduced ability to pay attention to the environment, memory impairment, disorientation, language and perception disturbances(1). Its occurrence varies between 20 and 90% in people hospitalized in the Intensive Care Unit (ICU) (2,3), with a duration between 1 and 5 days (2,3). Its hypoactive typology is frequent between 5 and 71.5% of the cases, hyperactive between 5.1 and 14%, and mixed between 5.1 and 89%. Its shows high variability in both incidence and typology, representing a phenomenon of great interest to nursing, who can make timely interventions.
Various studies have found that the etiology of delirium is associated with predisposing and precipitating factors. Among the predisposing factors, there is age between 50 and 70 years (4). Also chronic kidney disease, cerebrovascular disorders and a previous history of delirium, cognitive dysfunction, depression, dementia, dependence on psychoactive substances and / or alcohol, postoperative states, arterial hypertension, disease severity, elevated blood urea nitrogen and creatinine, sodium and hyperthermia(4).
Among the precipitating factors of delirium are mechanical ventilation (5), benzodiazepines (2), low scores in the RASS scale (5), pain, stress, interruption of the sleep-wake cycle, physical immobilizations, and medical devices such as urinary catheter and central venous catheter. These factors are specific to the environment and ICU treatment and increase the risk of delirium, regardless of the presence or absence of predisposing factors. However, the precipitating factors are modifiable according to the diagnosis and evolution of the patient.
Its impact is highly negative since it increases the days of mechanical ventilation, of consciousness in deep sedation (5), stay and mortality in ICU and hospital (2), of the use of physical restraints accelerates the transition to dementia and reduces cognitive recovery, and physical functionality(3). For this reason, the American Guidelines of 2013 and 2018 and German of 2015 for the management of agitation, pain, and delirium, recommend monitoring and preventing it through mainly non-pharmacological measures, which is part of the strategy of humanization of care in the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be triple-blind, since the participants and their relatives, the research assistant who measures the outcome variables, and who performs the information analysis process, will not know the assignment of the study, control and intervention groups, due to They will be named by categories coded by the research assistant who performs the randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People admitted to the adult intensive care unit
- •People over 18 years of age.
- •People who are agree to participate in the study by signing the informed consent.
- •People who have no delirium at the time of recruitment (CAM - negative ICU).
排除标准
- •People with any cognitive disorder or neurosurgical pathology.
结局指标
主要结局
Changes in cognitive state, presence or absence of delirium with Confusion Assessment Method for the Intensive Care Unit CAM-ICU scale
时间窗: Through ICU length of stay, an average of 8 days.
The possible results are positive or negative for delirium
次要结局
- Mechanical ventilation(Through ICU length of stay, an average of 8 days)
- Physical restrictions(Through ICU length of stay, an average of 8 days.)
- length of stay in ICU(Through ICU length of stay, an average of 8 days.)
- Fluctuations in consciousness with Richmond Agitation-Sedation Scale (RASS).(Through ICU length of stay, an average of 8 days.)
- Changes in the Pain intensity. with Campbell scale in non-communicative critical patients, and Visual Analog Scale (VAS) in communicative critical patients.(Through ICU length of stay, an average of 8 days.)