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

NCT ID: NCT05936944

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 448 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2024-06-22

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.

Conditions

Intensive Care Unit Delirium; Postoperative Delirium; Cardiac Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Natural Light

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

No interventions assigned to this group

Artificial Light

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

Exposure to totally artificial lighting

Intervention Type: OTHER

The second group of patients will be admitted to an ICU without windows and with a totally artificial lighting

Interventions

Exposure to totally artificial lighting

The second group of patients will be admitted to an ICU without windows and with a totally artificial lighting

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role: lead

Responsible Party

Davide Nicolotti

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale Maggiore di Parma

Parma, PR, Italy

Countries

Italy

Other Identifiers

SIRER 6097

Identifier Type: -

Identifier Source: org_study_id