Role of Natural Light in the Prevention of Delirium After Cardiac Surgery: a Prospective Observational Study With Historical Control (iWOnDer)

Azienda Ospedaliero-Universitaria di Parma

Status: Completed

Conditions: Cardiac Surgery; Intensive Care Unit Delirium; Postoperative Delirium

Treatments: Other: Exposure to totally artificial lighting

Study type: Observational

Funder types: Other

Identifiers

NCT05936944

SIRER 6097

Details and patient eligibility

About

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.

Enrollment: 448 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

448 participants in 2 patient groups

Natural Light

Description:

Group of patients enrolled in the first ICU, with natural lighting

Artificial Light

Description:

Group of patients enrolled in the second ICU, with totally artificial lighting

Treatment:

Other: Exposure to totally artificial lighting