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ABCDEF Bundle Compliance and ICU Outcomes in Latin America

20. srpna 2026 aktualizováno: 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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

580

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Jiný: ABCDEF Bundle Compliance Assessment
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.
Jiný: ABCDEF Bundle Compliance Assessment
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.
Jiný: ABCDEF Bundle Compliance Assessment
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
ICU Delirium Prevalence
Časové okno: 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
Časové okno: 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
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Functional Mobility at ICU Discharge
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hospital H+ Queretaro

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

24. srpna 2026

Primární dokončení (Odhadovaný)

24. listopadu 2026

Dokončení studie (Odhadovaný)

30. listopadu 2026

Termíny zápisu do studia

První předloženo

17. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

20. srpna 2026

První zveřejněno (Aktuální)

24. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

24. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CEI2026-08/15/V1

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