Delirium Confusional State / Delirium in Old Age / Control group · Interventional Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned randomized trial comparing a structured non-pharmacologic delirium prevention bundle to usual care in older cardiac intensive care patients aged ≥70 years. No results have been posted in this registry record; the study is actively enrolling or has completed enrollment but outcome data are not yet available for analysis.
Interventional, Randomized, Parallel, Single masking, Prevention purpose. Delirium in Old Age, Delirium in the Intensive Care Unit, Delirium Confusional State, Delirium, Cardiac Intensive Care Unit, Frailty in Older Adults, Acute Cor…; age from 70 Years. Intervention: Intervention Group; Control Group. Compared with: Usual CICU care, including routine delirium screening with CAM-ICU according to unit practice.. n = 200. 1 site: Israel.
This is a planned randomized trial comparing a structured non-pharmacologic delirium prevention bundle to usual care in older cardiac intensive care patients aged ≥70 years. No results have been posted in this registry record; the study is actively enrolling or has completed enrollment but outcome data are not yet available for analysis.
This is a registry record with no reported results; efficacy, safety, and outcome data are not available.
Once results are available, this trial may provide evidence on whether a multicomponent non-pharmacologic bundle reduces delirium incidence and improves cardiac and functional outcomes in older CICU patients. Current registry data permit only assessment of design quality and planned comparisons, not clinical utility.
This is a clinical trial registry record with no reported results; the study is active but not recruiting, making it an ongoing registration with planned enrollment and outcome measures but no efficacy or safety data yet available.
As stated by the source record.
Quoted from the source exactly as published.
Once results are available, this trial may provide evidence on whether a multicomponent non-pharmacologic bundle reduces delirium incidence and improves cardiac and functional outcomes in older CICU patients. Current registry data permit only assessment of design quality and planned comparisons, not clinical utility.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07776184). This is a study registration, not published results. Lead sponsor: Tel Aviv Medical Center. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). 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). Interventions: OTHER: Multicomponent Delirium Prevention Bundle; OTHER: Control Group. Primary outcome measures: Number of Participants Who Develop Delirium During Cardiac Intensive Care Unit Stay , From admission to the cardiac intensive care unit through discharge from the cardiac intensive care unit; MACE , From CICU admission through the geriatric cardiology clinic follow-up visit (up to 6 months).. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.