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

Cardiac Surgery Clinical Trial

— iWOnDer  

Official title:

Ruolo Della Luce Naturale Nella Prevenzione Del Delirium Dopo Cardiochirurgia: Studio Osservazionale Prospettico Con Controllo Storico

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936944
• Other study ID #: SIRER 6097
• Status: Recruiting
• Start date: June 14, 2023
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: Davide Nicolotti, MD
• Phone: 00390521703286
• Email: dnicolotti[@]ao.pr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2024
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Delirium
• Emergence Delirium
• Intensive Care Unit Delirium
• Postoperative Delirium

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Maggiore di Parma	Parma	PR

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative episodes of agitation	number of episodes of postoperative agitation (RASS>+1) requiring farmacological treatment	first five postoperative days or ICU discharge (wichever comes first)