Clinical Trials Directory

Trials / Completed

CompletedNCT05936944

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
448 (actual)
Sponsor
Azienda Ospedaliero-Universitaria di Parma · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2023-06-14
Primary completion
2024-06-22
Completion
2024-06-22
First posted
2023-07-10
Last updated
2025-10-02

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05936944. Inclusion in this directory is not an endorsement.