Trials / Completed
CompletedNCT05936944
Role of Natural Light in the Prevention of Delirium After Cardiac Surgery: a Prospective Observational Study With Historical Control
Ruolo Della Luce Naturale Nella Prevenzione Del Delirium Dopo Cardiochirurgia: Studio Osservazionale Prospettico Con Controllo Storico
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 448 (actual)
- Sponsor
- Azienda Ospedaliero-Universitaria di Parma · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-06-14
- Primary completion
- 2024-06-22
- Completion
- 2024-06-22
- First posted
- 2023-07-10
- Last updated
- 2025-10-02
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05936944. Inclusion in this directory is not an endorsement.