Automated Pupillometry in Patients Underwent Cardiac Surgery to Predict Postoperative Delirium

NCT06255132 | Unknown

• 1 other identifier: 4079CESC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium

Keywords

automated pupillometry; cardiac surgical procedures

Outcome Measures

Primary Outcomes (1)

• Correlation between neurological pupil index (NPi) and Post-operative delirium

  We want to relate pupillary reactivity, assessed with automated pupillometry such as the Neurological pupil index (numerical value:0-5) during surgery, with Postoperative delirium (assessed with CAM-ICU score during the first 5 postoperative days).

  Intraoperative (day 0)

Secondary Outcomes (4)

• Correlation between early prediction model for delirium (E-PRE-DELIRIC) and POD

  E-PREDELIRIC is calculated at ICU admission ( day 0)

• Correlation between regional cerebral saturation (rSO2) and POD occurrence

  rSO2 is monitored during surgery (Day 0)

• Correlation between Cardiopulmonary bypass duration and POD.

  Intraoperative

• Multivariate model for POD prediction.

  Day 0

Study Arms (1)

Patients undergoing open heart surgery

EXPERIMENTAL

Device: Automated pupillometer NPi-200

Interventions

Automated pupillometer NPi-200 DEVICE

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).

Patients undergoing open heart surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing elective open cardiac surgery (\>18 yr)
• Elective open cardiac surgery and cardiopulmonary bypass

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Unit of Cardiothoracic Anesthesia and Intensive Care, University hospital of Verona

Verona, Vr, 37126, Italy

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Leonardo Gottin, Prof.

  Universita di Verona

  STUDY DIRECTOR

• Federico Romagnosi, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Romagnosi, MD

CONTACT

0458122621; federico.romagnosi@aovr.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: February 13, 2024
• Study Start: March 9, 2023
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-01

Locations

IT (1)