Using automated pupillometry to predict delirium after heart surgery
Exploratory Study on the Role of Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium
This study is testing if a special eye measurement can help predict if adults will experience confusion after heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Locations | 1 site (Verona, Vr) |
| Trial ID | NCT06255132 on ClinicalTrials.gov |
What this trial studies
This study evaluates the potential of automated pupillometry to predict postoperative delirium in adult patients undergoing elective open cardiac surgery. By measuring various pupillary variables during anesthesia with an automated pupillometer, the researchers aim to identify correlations between these measurements and the occurrence of delirium post-surgery. Patients will be monitored closely in the cardiac intensive care unit after surgery to assess their cognitive status using the Confusion Assessment Method-ICU. The study seeks to validate a new predictive tool for a common complication in cardiac surgery.
Who should consider this trial
Good fit: Ideal candidates are adult patients over 18 years old scheduled for elective open cardiac surgery requiring cardiopulmonary bypass.
Not a fit: Patients under 18, those undergoing emergency surgeries, or individuals with psychiatric disorders or ocular problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting postoperative delirium, potentially improving patient outcomes and care strategies.
How similar studies have performed: While various predictors for postoperative delirium have been studied, the use of automated pupillometry in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients undergoing elective open cardiac surgery (\>18 yr) * Elective open cardiac surgery and cardiopulmonary bypass Exclusion Criteria: * Patients \<18 years of age * Emergency surgeries * Heart operations, not including extracorporeal circulation * Surgery for aortic arch dissection with hypothermia and/or circulatory arrest * Patients affected by psychiatric disorders undergoing with or without neuroleptic therapy * Patients who have the refused consent * Patients with ocular problems (acute or previous trauma to one or both eyes, blindness, ocular prosthesis)
Where this trial is running
Verona, Vr
- Unit of Cardiothoracic Anesthesia and Intensive Care, University hospital of Verona — Verona, Vr, Italy (Recruiting)
Study contacts
- Principal investigator: Federico Romagnosi, MD — Universita di Verona
- Study coordinator: Federico Romagnosi, MD
- Email: federico.romagnosi@aovr.veneto.it
- Phone: 0458122621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.