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NCT07776184
Multi-Component Delirium Prevention Bundle in Older Cardiac Intensive Care Unit Patients
Conditions: Delirium in Old Age, Delirium in the Intensive Care Unit, Delirium Confusional State, Delirium, Cardiac Intensive Care Unit, Frailty in Older Adults, Acute Coronary Syndromes (ACS)
Sex: All
Ages: 70 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Tel Aviv Medical Center
Location: Department of Cardiology, Sourasky University Medical Center Tel Aviv
Summary
The goal of this randomized controlled clinical trial is to learn whether a structured delirium prevention protocol can reduce the occurrence of delirium in older adults admitted to the cardiac intensive care unit (CICU). The study will include participants aged 70 years and older who are hospitalized in the CICU with acute cardiac conditions. The main questions it aims to answer are:
Does a structured non-pharmacologic delirium prevention protocol lower the incidence of delirium compared with usual care in older CICU patients? Does this protocol improve short- and long-term clinical outcomes, such as major adverse cardiac events (MACE), functional decline, and cognitive impairment? Researchers will compare participants randomly assigned to receive the delirium prevention protocol (intervention group) with participants receiving usual CICU care (control group) to see if the protocol leads to fewer episodes of delirium and better clinical and functional outcomes.
Participants will:
Be randomly assigned to the intervention group or the control group. Undergo daily delirium screening using the CAM-ICU tool. Be evaluated by an independent geriatrician who is not the principal investigator, and who will perform all clinical and geriatric assessments external to the treating CICU team.
In the intervention group, receive a structured prevention protocol that includes: daily pain assessment using the VAS scale and age-appropriate analgesia as needed, avoiding benzodiazepines when possible, use of earplugs and eye masks at night, early mobilization including bedside cycling exercises, and support for vision and hearing (use of glasses and hearing aids) and family presence overnight.
In the control group, receive usual CICU care, including delirium screening with CAM-ICU according to unit practice.
Eligibility Criteria
Inclusion Criteria:
* Age ≥70 years
* Expected CICU length of stay \>24 hours
* Willing to participate in the study
Exclusion Criteria:
* Age \
Source: ClinicalTrials.gov (NCT07776184). StuddyBuddy aggregates publicly available trial information.