An observational study in Intensive Care Unit Delirium, Postoperative Delirium and Cardiac Surgery, sponsored by Azienda Ospedaliero-Universitaria di Parma. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Azienda Ospedaliero-Universitaria di Parma · Observational
Postoperative delirium is a common complication that usually occurs acutely within the first 24 hours after surgery and resolves within 72 hours; it is common in all medical areas and particularly affects patients over the age of 65 and those with pre-existing cognitive impairments. It is characterized by difficulty organizing and coordinating thoughts and by slowing down motor functions that are observed for a short period after surgery.
The study will be an observational prospective study with historical control (pre/post-study) whose primary objective is to identify the incidence of postoperative delirium in patients undergoing cardiac surgery. The population will be adult patients undergoing cardiac surgery at our University Hospital over a period of 12 months. The intervention will be exposure to totally artificial light (for patients hospitalized after the relocation of the department to its original location). The comparator will be exposure to natural light (for patients who will be hospitalized during our temporary transfer to an environment with natural lighting). The outcome will be the incidence of delirium, measured with the Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale; episodes of agitation requiring sedative drugs; time elapsed before onset of delirium. The study will last 12 months.
763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.
This study's enrollment of 448 is above the median of 164 across 280 observational studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Azienda Ospedaliero-Universitaria di Parma is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
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All adult patients undergoing cardiac surgery with planned postoperative ICU admission. All tipes of cardiac surgery, irrespective of surgical access or technique, but excluding surgery performed under total circulatory arrest (totale suspension of brain perfusion). Patients will be excluded if they are unable to perform CAM-ICU assessment, if they were diagnosed with major depression or moderate/severe dementia and if they were already in ICU before surgery. Emergent surgery will also be an exclusion criteria.
Exclusion Criteria:
Group of patients enrolled in the first ICU, with natural lighting
Group of patients enrolled in the second ICU, with totally artificial lighting
Other: Exposure to totally artificial lighting
The second group of patients will be admitted to an ICU without windows and with a totally artificial lighting
Postoperative delirium
Occurrence of delirium, diagnosed with at least one positive CAM-ICU evaluation
Time frame: first five postoperative days or ICU discharge (wichever comes first)
Postoperative episodes of agitation
number of episodes of postoperative agitation (RASS\>+1) requiring farmacological treatment
Time frame: first five postoperative days or ICU discharge (wichever comes first)
Plan to share: Undecided
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Azienda Ospedaliero-Universitaria di Parma