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OpenTrials
Completed

NCT Number: NCT05936944

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Postoperative delirium

    Time frame: first five postoperative days or ICU discharge (wichever comes first)

    Occurrence of delirium, diagnosed with at least one positive CAM-ICU evaluation

Secondary outcomes

  1. Postoperative episodes of agitation

    Time frame: first five postoperative days or ICU discharge (wichever comes first)

    number of episodes of postoperative agitation (RASS>+1) requiring farmacological treatment

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Official study title

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

Acronym: iWOnDer

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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