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ABCDEF Bundle Compliance and ICU Outcomes in Latin America

20 août 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

580

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: 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.
Autre: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
ICU Delirium Prevalence
Délai: 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
Délai: 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
Délai: 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).

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Functional Mobility at ICU Discharge
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital H+ Queretaro

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

24 août 2026

Achèvement primaire (Estimé)

24 novembre 2026

Achèvement de l'étude (Estimé)

30 novembre 2026

Dates d'inscription aux études

Première soumission

17 août 2026

Première soumission répondant aux critères de contrôle qualité

20 août 2026

Première publication (Réel)

24 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CEI2026-08/15/V1

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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