iWOnDer: Role of Natural Light in the Prevention of Delirium After Cardiac Surgery: a Prospective Observational Study With Historical Control
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Natural Light Group of patients enrolled in the first ICU, with natural lighting |
|
| Artificial Light 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
|
Outcome Measures
Primary Outcome Measures
- Postoperative delirium [first five postoperative days or ICU discharge (wichever comes first)]
Occurrence of delirium, diagnosed with at least one positive CAM-ICU evaluation
Secondary Outcome Measures
- Postoperative episodes of agitation [first five postoperative days or ICU discharge (wichever comes first)]
number of episodes of postoperative agitation (RASS>+1) requiring farmacological treatment
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ospedale Maggiore di Parma | Parma | PR | Italy | 43126 |
Sponsors and Collaborators
- Azienda Ospedaliero-Universitaria di Parma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SIRER 6097