Optic Nerve Sheath Diameter is Associated With Postoperative Delirium in Patients Undergoing Open Heart Surgery

Completed

• Conditions: Delirium, Postoperative; Cardiac Valve Disease; Cardiac Disease
• Interventions: Diagnostic Test: ONSD

• Registration Number: NCT05942183
• Lead Sponsor: Samsun University

Brief Summary

Although the incidence of delirium after cardiac surgery is high, it is not sufficiently recognized. The long-term effects of delirium are likely to be underestimated. In this study, the investigators aimed to examine the relationship between optic nerve sheath diameter and postoperative delirium in open hearth surgery.

Detailed Description

Postoperative delirium is characterized by widespread brain involvement and its incidence is between 6% and 30%. It appears twice as often after cardiac and vascular surgery than other types of surgery. The correlation between optic nerve sheath diameter (ONSD) and invasive intracranial pressure measurement is excellent. ONSD reduction has the potential to indicate intracranial hypoperfusion causing delirium. In this observational study, patients aged 18 years and over who will undergo open heart surgery will be examined. ONSD will be measured using ultrasound five times in the perioperative period (t0: pre-induction, t1: post-induction, t2: onset of cardiopulmonary bypass (CPB), t3: post-CPB, and t4: post-ICU admission). The Confusion Assessment Method for the ICU (CAM-ICU) test will be used to examine delirium in the ICU. Whether the change in ONSD is an independent risk factor for delirium will be evaluated.

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-12
• Study Start: 2023-08-07
• Status Verified: 2024-06
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-12
• Last Update Submitted: 2024-06-13
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• ≥18 year old
• Elective open heart surgery

Exclusion Criteria

• psychiatric illness
• neurological disease
• ophthalmic disease
• previous eye surgery
• perioperative cerebrovascular disease
• need for postoperative intraaortic balloon or extracorporeal support system

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAM-ICU positive	ONSD	delirium positive
CAM-ICU negative	ONSD	delirium negative

Primary Outcome Measures

Name	Time	Method
Incidence of delirium after open heart surgery	6 months	Using the CAM-ICU test for delirium definition
The relationship between ONSD and postoperative delirium in cardiac surgery	6 months	Peroperatively measured ONSD will be compared with the development of postoperative delirium.

Trial Locations

Locations (1)

Aynur Kaynar; 🇹🇷 Samsun, Turkey