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

NCT05936944 | Completed

• 1 other identifier: SIRER 6097
• Study Type: observational
• Target: 448
• Locations: 1 country
• Sites: 1

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

Keywords

cardiac surgery; postoperative delirium; natural light

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative episodes of agitation

  first five postoperative days or ICU discharge (wichever comes first)

Study Arms (2)

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

Interventions

Exposure to totally artificial lighting OTHER

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

Artificial Light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients undergoing cardiac surgery with planned postoperative ICU admission. All tipes of cardiac surgery, irrespective of surgical access or technique, but excluding surgery performed under total circulatory arrest (totale suspension of brain perfusion). Patients will be excluded if they are unable to perform CAM-ICU assessment, if they were diagnosed with major depression or moderate/severe dementia and if they were already in ICU before surgery. Emergent surgery will also be an exclusion criteria.

You may qualify if:

• planned cardiac surgery
• planned ICU admission after surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (1)

Ospedale Maggiore di Parma

Parma, PR, 43126, Italy

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: June 14, 2023
• Primary Completion: June 22, 2024
• Study Completion: June 22, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

IT (1)