NCT06255132

Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium

Exploratory Study on the Role of Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The rate of postoperative delirium in patients who underwent cardiac surgery is very high. Different predictors and/or scores were studied for the prediction of Post Operative Delirium (POD)after heart surgery, but none of them was validated. The investigators aim to explore the role of pupillary alterations during anesthesia in open-heart surgery. The goal of this prospective study is to evaluate if pupil alterations during cardiac surgery, evaluated by an automated pupillometer (NPi-200) ( AP), could predict postoperative delirium.

Detailed description

Consent was obtained during the hospitalization before the planned surgery. On the day of surgery, before general anesthesia is started, Near-infrared spectroscopy (NIRS) sensors are applied to the patient's forehead bilaterally and the baseline value is recorded. Pupils' variables (i.e., diameter, % constriction, constriction velocity, dilation velocity, latency, NPi) are also recorded from both the right and left eye with AP (NPi-200). From the induction of anesthesia, pupillary variables in both eyes are recorded and measured every 30' such as the concomitant NIRS values (at least one measurement per eye per operative phase). Moreover, hemodynamic and respiratory parameters concomitant with the pupillary measurements are measured. Following surgery, the patient is transferred to the Cardiac Intensive Care Unit. There, NIRS monitoring as as well as automated pupillometry measurements will be maintained until the patient regains consciousness (defined as RASS sedation scale \>-3). Once the patient has regained consciousness (RASS\>-3), is assessed twice a day (morning and afternoon) with the Confusion assessment method-intensive care unit (CAM-ICU) score by the nursing staff and/or medical staff. The presence or absence of POD will then be reported as well as any pharmacological and non-pharmacological treatments. Any neurological complications and diagnostic investigations arising in the post-operative period will also be noted.

Conditions

• Postoperative Delirium

Interventions

Type	Name	Description
DEVICE	Automated pupillometer NPi-200	Pupillary variables in both eyes are recorded and measured with NPi-200 every 30 minutes from the induction of anesthesia. At the end of the surgery, the patient is transferred to the intensive care unit (ICU), and the pupillary variables are recorded until the patient regains consciousness (Richmond agitation sedation scale, RASS\>-3). Specific hemodynamic, respiratory, surgical, and EBP data are also recorded as well as NIRS variables. As soon as the patient had regained consciousness (RASS \> 3), they were assessed for delirium for a total period of five days. Nursing and/or medical staff administered the CAM-ICU score to patients twice a day (morning and afternoon).

Timeline

• Start date: 2023-03-09
• Primary completion: 2024-09-01
• Completion: 2025-03-01
• First posted: 2024-02-13
• Last updated: 2024-02-13

Locations

1 site across 1 country: Italy