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

Recruiting

• Conditions: Intensive Care Unit Delirium; Postoperative Delirium; Cardiac Surgery
• Interventions: Other: Exposure to totally artificial lighting

• Registration Number: NCT05936944
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-14
• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Status Verified: 2023-07
• Study First Posted: 2023-07-10
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20
• Primary Completion: 2024-06-14
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Artificial Light	Exposure to totally artificial lighting	Group of patients enrolled in the second ICU, with totally artificial lighting

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Ospedale Maggiore di Parma; 🇮🇹 Parma, PR, Italy