ABCDEF Bundle Compliance and Outcomes in Latin American Intensive Care Units: An International Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 580
- 主要终点
- ICU Delirium Prevalence
研究概览
简要总结
The goal of this observational study is to evaluate the degree of compliance with the ABCDEF bundle and its relationship with clinical outcomes in adult patients (aged 18 and older) admitted to intensive care units (ICUs) in Latin America for at least 48 hours.
The main questions it aims to answer are: What is the prevalence, cumulative incidence, and duration of delirium in adult ICU patients in Latin America? Is higher compliance with the ABCDEF bundle (low [<33%], moderate [33%-66%], high [>66%]) independently associated with a lower prevalence, cumulative incidence, and duration of delirium? Does higher ABCDEF bundle compliance improve functional mobility at hospital discharge and long-term cognitive, psychological, and quality-of-life outcomes at 3 and 6 months post-discharge? Researchers will compare three groups based on their level of ABCDEF bundle compliance (low [<33%], moderate [33%-66%], and high [>66%]) to see if higher bundle adherence improves delirium and long-term post-ICU functional outcomes.
Participants will:
Receive standard ICU care without experimental intervention. Undergo daily assessments for delirium (using CAM-ICU) and physical mobility (using ICU Mobility Scale) during their ICU stay.
Complete telephone follow-up evaluations at 3 months post-discharge to assess cognitive function (BCAT-ICU/MoCA) and psychological symptoms (HADS, DSPS).
Complete follow-up evaluations at 6 months post-discharge to assess cognitive function (full MoCA), psychological symptoms (HADS, DSPS), and health-related quality of life (EQ-5D-5L).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years Admission to the ICU during the 3-month recruitment period
- •Expected ICU length of stay ≥48 hours
- •Written informed consent provided by the patient or legal representative (or eligibility for deferred consent according to local regulations)
排除标准
- •History of moderate to severe dementia
- •Severe chronic brain disease (e.g., previous disabling stroke, Parkinson's disease, advanced multiple sclerosis)
- •Severe prior intellectual disability or prior functional cognitive dependence
- •Palliative sedation scheduled from ICU admission
- •Deep irreversible coma or diagnosed brain death
- •Uncorrected bilateral deafness
- •Non-Spanish speakers
- •Refusal or explicit request by the family not to participate
结局指标
主要结局
ICU Delirium Prevalence
时间窗: Daily during the ICU stay (up to hospital discharge or a maximum of 30 days)
Percentage of adult patients experiencing delirium at any point during their ICU stay, evaluated daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
ICU Delirium Cumulative Incidence
时间窗: Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
Percentage of patients without delirium at ICU admission who subsequently develop delirium during their ICU stay, assessed daily using the CAM-ICU.
ICU Delirium Duration
时间窗: Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
Total number of days with delirium during the ICU stay, calculated from daily CAM-ICU assessments.
次要结局
- Functional Mobility at ICU Discharge(Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days))
- Achievement of Standing or Walking at ICU Discharge(Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days).)
- In-Hospital Mortality(From ICU admission up to hospital discharge (approximately 30 days).)
- Post-ICU Cognitive Function at 3 Months(3 months post-hospital discharge)
- Post-ICU Cognitive Function at 6 Months(6 months post-hospital discharge.)
- Post-Traumatic Stress Symptoms at 3 Months(3 months post-hospital discharge.)
- Post-Traumatic Stress Symptoms at 6 Months(6 months post-hospital discharge.)
- Hospital Anxiety and Depression Scale - Anxiety Subscale at 3 Months(3 months post-hospital discharge.)
- Hospital Anxiety and Depression Scale - Depression Subscale at 3 Months(3 months post-hospital discharge.)
- Hospital Anxiety and Depression Scale - Anxiety Subscale at 6 Months(6 months post-hospital discharge.)
- Hospital Anxiety and Depression Scale - Depression Subscale at 6 Months(6 months post-hospital discharge.)
- EQ-5D-5L Index Score at 6 Months(6 months post-hospital discharge.)
- EQ-5D Visual Analog Scale (EQ-VAS) Score at 6 Months(6 months post-hospital discharge.)
研究者
Jose J Zaragoza, MD MSc
Principal Investigator
Hospital H+ Queretaro