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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05936944
Other study ID # SIRER 6097
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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