ABCDEF Bundle Compliance and ICU Outcomes in Latin America
2026. augusztus 20. frissítette: 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).
A tanulmány áttekintése
Állapot
Még nincs toborzás
Beavatkozás / kezelés
Tanulmány típusa
Megfigyelő
Beiratkozás (Becsült)
580
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Job Heriberto Rodriguez Guillen
- Telefonszám: 52 5549636548
- E-mail: job.rodriguez@hospitalesmac.com
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
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
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
ICU Delirium Prevalence
Időkeret: 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
Időkeret: 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
Időkeret: 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).
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Functional Mobility at ICU Discharge
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. augusztus 24.
Elsődleges befejezés (Becsült)
2026. november 24.
A tanulmány befejezése (Becsült)
2026. november 30.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. augusztus 17.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 20.
Első közzététel (Tényleges)
2026. augusztus 24.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. augusztus 24.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 20.
Utolsó ellenőrzés
2026. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CEI2026-08/15/V1
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .