Critical Illness, Icu Delirium, Post Intensive Care Syndrome
Conditions
Keywords
ABCDEF Bundle, Delirium, Intensive Care, Post Intensive Care Syndrome
Brief 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).
Interventions
OTHERABCDEF 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
Hospital H+ Queretaro
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU Delirium Duration | 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. |
| ICU Delirium Prevalence | 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). |
| ICU Delirium Cumulative Incidence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale - Anxiety Subscale at 6 Months | 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). |
| Functional Mobility at ICU Discharge | 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. |
| Achievement of Standing or Walking at ICU Discharge | 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. |
| In-Hospital Mortality | From ICU admission up to hospital discharge (approximately 30 days). | Proportion of patients who died prior to hospital discharge. |
| Hospital Anxiety and Depression Scale - Depression Subscale at 6 Months | 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). |
| Post-ICU Cognitive Function at 6 Months | 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). |
| Post-Traumatic Stress Symptoms at 3 Months | 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). |
| Post-Traumatic Stress Symptoms at 6 Months | 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). |
| EQ-5D-5L Index Score at 6 Months | 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). |
| EQ-5D Visual Analog Scale (EQ-VAS) Score at 6 Months | 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). |
| Post-ICU Cognitive Function at 3 Months | 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. |
| Hospital Anxiety and Depression Scale - Anxiety Subscale at 3 Months | 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). |
| Hospital Anxiety and Depression Scale - Depression Subscale at 3 Months | 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). |
Contacts
CONTACTJob Heriberto Rodriguez Guillen
Outcome results
None listed