Optic Nerve Sheath After Extracorporeal Circulation

Completed

• Conditions: Cardiac Disease; Cardiac Valve Disease
• Interventions: Diagnostic Test: ultrasound measurement of the optic nerve sheath diameter; Diagnostic Test: MoCA test

• Registration Number: NCT05335902
• Lead Sponsor: University Medical Centre Maribor

Brief Summary

The purpose of this study is to assess the influence of extracorporeal circulation during cardiac surgery on the optic nerve sheath diameter (ONSD) after the surgery.

Detailed Description

ONSD will be measured before and 1 hour after the surgery and in the morning of day 1 after the surgery. Fluid balance and lactate will be measured too. PONV will be assessed. Patients will be evaluated with MoCA test on the day before surgery and on the day 3 after the surgery for cognitive disfunction.

Study Timeline

• Study First Submitted: 2021-10-29
• Study Start: 2021-11-22
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-20
• Primary Completion: 2023-02-01
• Study Completion: 2024-06-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• heart surgery with use of cardiopulmonary bypass

Exclusion Criteria

• pregnancy and lactation
• neurologic disorders
• hyperthyroidism
• optic nerve disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
standard cardiopulmonary bypass	MoCA test	patients 18 year or older undergoing heart surgery with standard cardiopulmonary bypass
mini-cardiopulmonary bypass	MoCA test	patients 18 year or older undergoing heart surgery with standard mini-cardiopulmonary bypass
standard cardiopulmonary bypass	ultrasound measurement of the optic nerve sheath diameter	patients 18 year or older undergoing heart surgery with standard cardiopulmonary bypass
mini-cardiopulmonary bypass	ultrasound measurement of the optic nerve sheath diameter	patients 18 year or older undergoing heart surgery with standard mini-cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
Ultrasound measuring of optic nerve sheath diameter baseline	Before start of surgery	Baseline optic nerve sheath diameter measurement before start of surgery with a linear ultrasound probe (Scan) in coronal and axial plane
Ultrasound measuring of optic nerve sheath diameter end of surgery	1 hour after the end of surgery	Optic nerve sheath diameter measurement 1 hour after the end of surgery with a linear ultrasound probe in coronal and axial plane
Ultrasound measuring of optic nerve sheath diameter day 1	day 1 after the surgery	Optic nerve sheath diameter measurement in the morning on day 1 after the surgery with a linear ultrasound probe in coronal and axial plane

Secondary Outcome Measures

Name	Time	Method
postoperative cognitive disfunction measured with the MoCA test	on the day before surgery, on day 3 after the surgery	MoCA test is a validated test for cognitive disfunction, especially in patients who are elderly than 60 years, the study is comparing the MoCA test values on the day before surgery with the values on day 3 after the surgery
postoperative nausea and vomiting (PONV)	during the first 24 hours after surgery	Postoperative nausea and vomiting is common after cardiac surgery, the occurrence of postoperative nausea and vomiting will be recorded

Trial Locations

Locations (1)

University medical centre Maribor; 🇸🇮 Maribor, Slovenia