Cardiac Surgery Clinical Trial
— iWOnDerOfficial title:
Ruolo Della Luce Naturale Nella Prevenzione Del Delirium Dopo Cardiochirurgia: Studio Osservazionale Prospettico Con Controllo Storico
NCT number | NCT05936944 |
Other study ID # | SIRER 6097 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 14, 2023 |
Est. completion date | October 2024 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | October 2024 |
Est. primary completion date | June 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - planned cardiac surgery - planned ICU admission after surgery Exclusion Criteria: - cardiac surgery with total suspension of cerebral perfusion - patient with diagnosed dementia or major depressive disorder - patient unable to perform CAM-ICU evaluation - emergent surgery - patient in ICU before surgery |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Maggiore di Parma | Parma | PR |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria di Parma |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative delirium | Occurrence of delirium, diagnosed with at least one positive CAM-ICU evaluation | first five postoperative days or ICU discharge (wichever comes first) | |
Secondary | Postoperative episodes of agitation | number of episodes of postoperative agitation (RASS>+1) requiring farmacological treatment | first five postoperative days or ICU discharge (wichever comes first) |
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