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).
調査の概要
研究の種類
観察的
入学 (推定)
580
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Job Heriberto Rodriguez Guillen
- 電話番号：52 5549636548
- メール：job.rodriguez@hospitalesmac.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ICU Delirium Prevalence
時間枠：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
時間枠：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
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional Mobility at ICU Discharge
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月24日
一次修了 (推定)
2026年11月24日
研究の完了 (推定)
2026年11月30日
試験登録日
最初に提出
2026年8月17日
QC基準を満たした最初の提出物
2026年8月20日
最初の投稿 (実際)
2026年8月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月24日
QC基準を満たした最後の更新が送信されました
2026年8月20日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。