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ABCDEF Bundle Compliance and ICU Outcomes in Latin America

20. August 2026 aktualisiert von: 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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

580

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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.
Sonstiges: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
ICU Delirium Prevalence
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Functional Mobility at ICU Discharge
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hospital H+ Queretaro

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

24. August 2026

Primärer Abschluss (Geschätzt)

24. November 2026

Studienabschluss (Geschätzt)

30. November 2026

Studienanmeldedaten

Zuerst eingereicht

17. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. August 2026

Zuerst gepostet (Tatsächlich)

24. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CEI2026-08/15/V1

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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