ABCDEF Bundle Compliance and ICU Outcomes in Latin America
2026年8月20日 更新者：Jose J Zaragoza, MD MSc、Hospital H+ Queretaro
ABCDEF Bundle Compliance and Outcomes in Latin American Intensive Care Units: An International Multicenter Prospective Observational Study
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).
研究概览
研究类型
观察性的
注册 (估计的)
580
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Job Heriberto Rodriguez Guillen
- 电话号码：52 5549636548
- 邮箱：job.rodriguez@hospitalesmac.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adult critically ill patients admitted to six multipurpose intensive care units across four Latin American countries (Colombia, Mexico, Chile, and Argentina) with an expected ICU stay of at least 48 hours
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Low ABCDEF Bundle Compliance
Adult ICU patients who receive less than 33% of the ABCDEF bundle components (0 to 1 out of 6 components implemented) during their ICU stay.
|
Observational assessment of routine ICU clinical care practices implementing the ABCDEF bundle components (A: Sedation Assessment, B: Spontaneous Breathing Trials, C: Choice of Anesthesia/Sedation, D: Delirium Assessment and Management, E: Early Mobility, F: Family Engagement).
No experimental intervention is assigned by the study protocol.
|
|
Moderate ABCDEF Bundle Compliance
Adult ICU patients who receive between 33% and 66% of the ABCDEF bundle components (2 to 4 out of 6 components implemented) during their ICU stay.
|
Observational assessment of routine ICU clinical care practices implementing the ABCDEF bundle components (A: Sedation Assessment, B: Spontaneous Breathing Trials, C: Choice of Anesthesia/Sedation, D: Delirium Assessment and Management, E: Early Mobility, F: Family Engagement).
No experimental intervention is assigned by the study protocol.
|
|
High ABCDEF Bundle Compliance
Adult ICU patients who receive more than 66% of the ABCDEF bundle components (5 to 6 out of 6 components implemented) during their ICU stay.
|
Observational assessment of routine ICU clinical care practices implementing the ABCDEF bundle components (A: Sedation Assessment, B: Spontaneous Breathing Trials, C: Choice of Anesthesia/Sedation, D: Delirium Assessment and Management, E: Early Mobility, F: Family Engagement).
No experimental intervention is assigned by the study protocol.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ICU Delirium Prevalence
大体时间：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).
|
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days)
|
|
ICU Delirium Cumulative Incidence
大体时间：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.
|
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
|
|
ICU Delirium Duration
大体时间：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.
|
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Functional Mobility at ICU Discharge
大体时间：Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days)
|
Physical mobility evaluated using the ICU Mobility Scale (ICUMS), an 11-point scale ranging from 0 (nothing/lying in bed) to 10 (walking independently without a walking aid).
Higher scores represent better physical mobility and functional status.
|
Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days)
|
|
Achievement of Standing or Walking at ICU Discharge
大体时间：Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days).
|
Percentage of patients reaching a functional mobility level of at least standing at bedside or walking (defined as an ICU Mobility Scale score ≥ 4) before ICU discharge.
|
Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days).
|
|
In-Hospital Mortality
大体时间：From ICU admission up to hospital discharge (approximately 30 days).
|
Proportion of patients who died prior to hospital discharge.
|
From ICU admission up to hospital discharge (approximately 30 days).
|
|
Post-ICU Cognitive Function at 3 Months
大体时间：3 months post-hospital discharge
|
Global cognitive performance assessed using either the BCAT-ICU or the T-MoCA.
Scores range from 0 to 30 for BCAT-ICU (and 0 to 22 for T-MoCA), where higher scores indicate better cognitive performance.
|
3 months post-hospital discharge
|
|
Post-ICU Cognitive Function at 6 Months
大体时间：6 months post-hospital discharge.
|
Global cognitive performance assessed using the full Montreal Cognitive Assessment (MoCA).
Scores range from 0 to 30, where higher scores represent better cognitive function (a score of 26 or above is considered normal).
|
6 months post-hospital discharge.
|
|
Post-Traumatic Stress Symptoms at 3 Months
大体时间：3 months post-hospital discharge.
|
Psychological post-traumatic stress symptoms assessed using the 17-item Davidson Trauma Scale (DSPS).
Total scores range from 0 to 136, where higher scores indicate greater frequency and severity of post-traumatic stress symptoms (worse outcome).
|
3 months post-hospital discharge.
|
|
Post-Traumatic Stress Symptoms at 6 Months
大体时间：6 months post-hospital discharge.
|
Psychological post-traumatic stress symptoms assessed using the 17-item Davidson Trauma Scale (DSPS).
Total scores range from 0 to 136, where higher scores indicate greater frequency and severity of post-traumatic stress symptoms (worse outcome).
|
6 months post-hospital discharge.
|
|
Hospital Anxiety and Depression Scale - Anxiety Subscale at 3 Months
大体时间：3 months post-hospital discharge.
|
Psychological distress regarding anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A).
Scores range from 0 to 21, where higher scores indicate greater severity of anxiety symptoms (worse outcome; scores ≥ 8 suggest clinical anxiety).
|
3 months post-hospital discharge.
|
|
Hospital Anxiety and Depression Scale - Depression Subscale at 3 Months
大体时间：3 months post-hospital discharge.
|
Psychological distress regarding depression symptoms assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D).
Scores range from 0 to 21, where higher scores indicate greater severity of depressive symptoms (worse outcome; scores ≥ 8 suggest clinical depression).
|
3 months post-hospital discharge.
|
|
Hospital Anxiety and Depression Scale - Anxiety Subscale at 6 Months
大体时间：6 months post-hospital discharge.
|
Psychological distress regarding anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A).
Scores range from 0 to 21, where higher scores indicate greater severity of anxiety symptoms (worse outcome).
|
6 months post-hospital discharge.
|
|
Hospital Anxiety and Depression Scale - Depression Subscale at 6 Months
大体时间：6 months post-hospital discharge.
|
Psychological distress regarding depression symptoms assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D).
Scores range from 0 to 21, where higher scores indicate greater severity of depressive symptoms (worse outcome).
|
6 months post-hospital discharge.
|
|
EQ-5D-5L Index Score at 6 Months
大体时间：6 months post-hospital discharge.
|
Self-reported health status and quality of life evaluated across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
The index utility score ranges approximately from -0.6 to 1.0 (depending on national value sets), where higher scores represent better health-related quality of life (1.0 = perfect health).
|
6 months post-hospital discharge.
|
|
EQ-5D Visual Analog Scale (EQ-VAS) Score at 6 Months
大体时间：6 months post-hospital discharge.
|
Self-rated overall health status assessed using the EQ-5D Visual Analog Scale (EQ-VAS).
Scores range from 0 to 100 mm, where 0 represents the worst health you can imagine and 100 represents the best health you can imagine (higher scores represent better outcome).
|
6 months post-hospital discharge.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月24日
初级完成 (估计的)
2026年11月24日
研究完成 (估计的)
2026年11月30日
研究注册日期
首次提交
2026年8月17日
首先提交符合 QC 标准的
2026年8月20日
首次发布 (实际的)
2026年8月24日
研究记录更新
最后更新发布 (实际的)
2026年8月24日
上次提交的符合 QC 标准的更新
2026年8月20日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.