ABCDEF Bundle Compliance and ICU Outcomes in Latin America
20. august 2026 oppdatert av: 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).
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Antatt)
580
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Job Heriberto Rodriguez Guillen
- Telefonnummer: 52 5549636548
- E-post: job.rodriguez@hospitalesmac.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
ICU Delirium Prevalence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Mobility at ICU Discharge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
24. august 2026
Primær fullføring (Antatt)
24. november 2026
Studiet fullført (Antatt)
30. november 2026
Datoer for studieregistrering
Først innsendt
17. august 2026
Først innsendt som oppfylte QC-kriteriene
20. august 2026
Først lagt ut (Faktiske)
24. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CEI2026-08/15/V1
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