Intensive Care Unit DeliriumiWOnDerNCT05936944
Role of Natural Light in the Prevention of Delirium After Cardiac Surgery: a Prospective Observational Study With Historical Control
An observational study of Intensive Care Unit Delirium and Postoperative Delirium, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Delirium, Postoperative Delirium, Cardiac Surgery
- What is being tested?
- Exposure to totally artificial lighting
- How many people
- 448 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jun 2023to 22 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- planned cardiac surgery
- planned ICU admission after surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ruolo Della Luce Naturale Nella Prevenzione Del Delirium Dopo Cardiochirurgia: Studio Osservazionale Prospettico Con Controllo Storico
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.
- Being tested
- Exposure to totally artificial lighting
- Keywords
- cardiac surgery, postoperative delirium, natural light
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to totally artificial lightingOther
The second group of patients will be admitted to an ICU without windows and with a totally artificial lighting
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Exposure to totally artificial lighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
Occurrence of delirium, diagnosed with at least one positive CAM-ICU evaluation
Measured: first five postoperative days or ICU discharge (wichever comes first)
Secondary outcomes (1)
Postoperative episodes of agitation
number of episodes of postoperative agitation (RASS>+1) requiring farmacological treatment
Measured: first five postoperative days or ICU discharge (wichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start14 Jun 2023
- Primary completion22 Jun 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Nicolotti, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936944
- Sponsor's protocol ID
- SIRER 6097
- Acronym
- iWOnDer
- Status last verified
- Oct 2025
- First submitted
- 30 Jun 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruolo Della Luce Naturale Nella Prevenzione Del Delirium Dopo Cardiochirurgia: Studio Osservazionale Prospettico Con Controllo Storico
- ClinicalTrials.gov ID
- NCT05936944
- Acronym / sponsor ID
- iWOnDer / SIRER 6097
- Keywords
- cardiac surgery, postoperative delirium, natural light
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural Light | – | –Group of patients enrolled in the first ICU, with natural lighting |
| Artificial Light | – | Other: Exposure to totally artificial lightingGroup of patients enrolled in the second ICU, with totally artificial lighting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- planned cardiac surgery
- planned ICU admission after surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to totally artificial lightingThe second group of patients will be admitted to an ICU without windows and with a totally artificial lighting | Other | Artificial Light |
Primary outcome
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
1 secondary outcome
Postoperative episodes of agitation
Time frame: first five postoperative days or ICU discharge (wichever comes first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Delirium and Postoperative Delirium, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: first five postoperative days or ICU discharge (wichever comes first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.