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ABCDEF Bundle Compliance and ICU Outcomes in Latin America

NCT07783035 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 580

Last updated 2026-08-24

No results posted yet for this study

Summary

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).

Conditions

  • Icu Delirium
  • Post Intensive Care Syndrome
  • Critical Illness

Interventions

OTHER

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.

Sponsors & Collaborators

  • Hospital H+ Queretaro

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-24
Primary Completion
2026-11-24
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07783035 on ClinicalTrials.gov